EXHIBIT 9 Declaration of Rachel Clattenburg

Public Citizen v. FDA et al., 16-cv-781

Ex. 9, page 1

Ex. 9, page 2

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6/27/2016 Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia ­ Full Text View ­ ClinicalTrials.gov

https://clinicaltrials.gov/ct2/show/NCT00545974 1/6

This study has been completed.

Sponsor:University of California, San Francisco

Collaborator:Forest Laboratories

Information provided by (Responsible Party):University of California, San Francisco

ClinicalTrials.gov Identifier:NCT00545974

First received: October 16, 2007Last updated: December 13, 2013Last verified: December 2013History of Changes

Full Text View Tabular View Study Results Disclaimer How to Read a Study Record

A service of the U.S. National Institutes of Health

Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia

Purpose

The primary objective of the study is to determine whether memantine is effective in slowing the rate of behavioral decline in frontotemporaldementia.

The secondary objective of the study is to assess the safety and tolerability of long­term treatment with memantine in patients withfrontotemporal dementia (FTD) or semantic dementia (SD). To determine whether memantine is effective in slowing the rate of cognitive declinein frontotemporal dementia. To evaluate whether memantine delays or decreases the emergence of parkinsonism in frontotemporal dementia.

The tertiary objective of the study is to determine whether treatment with memantine affects changes in weight

Condition Intervention Phase

Frontal Lobe DementiaFrontotemporal Lobe DementiaSemantic Dementia

Drug: memantineDrug: Placebo pill

Phase 4

Study Type: InterventionalStudy Design: Allocation: Randomized

Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Official Title: A Prospective, Randomized, Multi­Center, Double­Blind, 26 Week, Placebo­Controlled Trial of Memantine (10mg BID) for theFrontal and Temporal Subtypes of Frontotemporal Dementia

Resource links provided by NLM:

Genetics Home Reference related topics: CHMP2B­related frontotemporal dementia GRN­related frontotemporal dementiafrontotemporal dementia with parkinsonism­17 inclusion body myopathy with early­onset Paget disease and frontotemporal dementia

MedlinePlus related topics: Dementia

Drug Information available for: Memantine Memantine hydrochloride

Genetic and Rare Diseases Information Center resources: Frontotemporal Dementia Frontotemporal Dementia, Ubiquitin­positivePick's Disease Primary Progressive Aphasia Semantic Dementia

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

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Change in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]

NPI:12­domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression,depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating,nighttime behavior. A screening question is asked about each sub­domain. If the responses to these questions indicate that the patient hasproblems with a particular sub­domain of behavior, the caregiver is only then asked all the questions about that domain, rating the frequencyof the symptoms on a 4­point scale, their severity on a 3­point scale, and the distress the symptom causes them on a 5­point scale.Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=eachdomain score(range 0­12). Total score=sum of each domain score(range 0­144);higher score=greater behavioral disturbances;negativechange score from baseline=improvement.

Clinical Global Impression of Change (CGIC) [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]

The scale is rated on a 7­point scale, using a range of responses from 1 (very much improved) through 7 (very much worse). The cliniciancompares the participant's current condition to the condition at admission to the project.

Secondary Outcome Measures:

CDR­FTD, MMSE, FAQ, TFLS, EXIT25, UCSF FTD­Neuropsychological Test Battery: CVLT, Verbal Fluency, Modified BNT, Backward DigitSpan, Digit Symbol Test, Modified Trails B, Modified Unified Parkinson's Disease Rating Scale, Antipsychotic Therapy [ Time Frame: 26Weeks ] [ Designated as safety issue: No ]

Enrollment: 81Study Start Date: October 2007Study Completion Date: December 2012Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions

Experimental: 1Memantine 10mg BID

Drug: memantinememantine 10mg BID

Placebo Comparator: 2Placebo condition

Drug: Placebo pillPlacebo pill BID

Detailed Description:

This is a multicenter, randomized, double­blind, placebo­controlled trial of memantine 10 mg twice daily versus placebo, at a ratio of 1:1, toreceive active drug or placebo. Screening and enrollment is planned to last approximately one year. A Data and Safety Monitoring Board,consisting of a clinical pharmacist and 3 neurologists will review all AE reports approximately every 3 months after study initiation. The DSMB willnotify the principal investigator, the study sponsor and the CHR if significant concerns are raised by their review of the AE data. An interimanalysis of efficacy data will be conducted after 50% of the targeted enrollment population has completed 26 weeks of drug treatment.

Including screening and off­drug follow up, each subject will participate in the study for approximately 34 weeks.

The entire study is anticipated to last 86 weeks if enrollment is completed within one year of study initiation.

The targeted enrollment is 140.

Eligibility

Ages Eligible for Study: 40 Years to 80 YearsGenders Eligible for Study: BothAccepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

A subject must meet ALL of the following criteria to be considered for enrollment in this study:

1. Signed and dated written informed consent obtained from the subject and the subject's caregiver in accordance with local IRB regulations.

2. Must meet criteria Neary et al. criteria for frontotemporal dementia (FTD) or semantic dementia (SD)

3. Age: 40­80

4. CT or MRI of brain within 12 months consistent with a diagnosis of FTD or SD.

5. MMSE ≥ 15 at screening visit.

6. Judged by investigator to be able to comply with neuropsychological evaluation at baseline.

7. Must have reliable caregiver accompany subject to all study visits. Caregiver must read, understand and speak English fluently in order to

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ensure comprehension of informed consent form and informant­based assessments of subject. Caregiver must also have frequentcontact with subject (at least 3 times per week for one hour) and be willing to monitor study medication compliance and the subject'shealth and concomitant medications throughout the study.

8. In the opinion of the investigator, the patient and the caregiver will be compliant with the protocol and have a high probability of completingthe study.

Exclusion Criteria:

Any one of the following will exclude a subject from being enrolled into the study:

1. Insufficient fluency in English to complete neuropsychological and functional assessments.

2. Concurrent Motor Neuron Disease judged by investigator to have bulbar or upper extremity impairments at baseline that would interferewith neuropsychological assessment, or that are expected to lead to such impairments within one month.

3. Exclusion criteria as listed in Neary criteria. Diagnosis of progressive nonfluent aphasia by Neary criteria.

4. Use of memantine within 4 weeks prior to randomization.

5. Evidence of other neurological or psychiatric disorders which preclude diagnosis of FTD (including, but not limited to, stroke, Parkinson'sdisease, any psychotic disorder, severe bipolar or unipolar depression, seizure disorder, or head injury with loss of consciousness) withinthe past year.

6. Concurrent treatment with acetylcholinesterase inhibitors, antipsychotic agents, mood stabilizers (valproate or lithium) or benzodiazepines(other than temazepam or zolpidem), or use of any of these agents within 4 weeks prior to randomization. Atypical antipsychotic agentsmay be started after the baseline visit if felt to be medically necessary by the investigator and will be recorded as a secondary outcomemeasure.

7. History of alcohol or substance abuse within 1 year prior to screening, if deemed clinically significant by investigator.

8. Any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal orneurological disease. If the condition has been stable for at least the past year and is judged by the investigator not to interfere with thepatient's participation in the study, the patient may be included.

9. Clinically significant lab abnormalities at screening, including Creatinine ≥ 1.7, B12 below laboratory normal reference range or TSH abovesite's laboratory normal reference range. Subjects with abnormal B12 or TSH levels at screening may be included per investigator'sdiscretion.

9. CT or MRI evidence of any of the following: hydrocephalus, stroke, space­occupying lesion, cerebral infection or any clinically significant CNSdisease other than FTD.

10.Systolic blood pressure greater than 180 or less than 90 mm Hg. Diastolic blood pressure greater than 105 or less than 50 mm Hg.

11. Abnormal ECG at screening judged to be clinically significant by the investigator.

12. Use of investigational drugs or participation in investigational drug study within 60 days of screening.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join astudy. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For generalinformation, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545974

Locations

United States, California

University of California, Los AngelesLos Angeles, California, United States, 90095

University California, San FranciscoSan Francisco, California, United States, 94143­1207

United States, Florida

Mayo Clinic ­ JacksonvilleJacksonville, Florida, United States, 32224

United States, Illinois

Northwestern UniversityChicago, Illinois, United States, 60611

United States, Maryland

Johns Hopkins HospitalBaltimore, Maryland, United States, 21205

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United States, Minnesota

Mayo Clinic ­ RochesterRochester, Minnesota, United States, 55905

United States, North Carolina

University of North Carolina at Chapel HillChapel Hill, North Carolina, United States, 27599­7025

United States, Ohio

University Hospitals of Cleveland / Case Medical CenterCleveland, Ohio, United States, 44120

United States, Pennsylvania

University of PennsylvaniaPhiladelphia, Pennsylvania, United States, 19104­4283

Sponsors and Collaborators

University of California, San Francisco

Forest Laboratories

Investigators

Principal Investigator: Adam L. Boxer, M.D., Ph.D. University of California, San Francisco

Principal Investigator: Bruce Miller, M.D. University of California, San Francisco

More Information

Additional Information:

UCSF Memory and Aging Center

Publications:

Amadoro G, Ciotti MT, Costanzi M, Cestari V, Calissano P, Canu N. NMDA receptor mediates tau­induced neurotoxicity by calpain andERK/MAPK activation. Proc Natl Acad Sci U S A. 2006 Feb 21;103(8):2892­7. Epub 2006 Feb 13.

Boxer AL, Miller BL. Clinical features of frontotemporal dementia. Alzheimer Dis Assoc Disord. 2005 Oct­Dec;19 Suppl 1:S3­6. Review.

Boxer AL, Trojanowski JQ, Lee VY­M, Miller BL (2005) Frontotemporal Lobar Degeneration. In: Neurodegenerative Diseases: Neurobiology,Pathogenesis and Therapeutics (Beal MF, Lang AE, Ludolph AC, eds), pp 481 ­ 493. Cambridge, UK: Cambridge University Press.

Cullum CM, Saine K, Chan LD, Martin­Cook K, Gray KF, Weiner MF. Performance­Based instrument to assess functional capacity in dementia:The Texas Functional Living Scale. Neuropsychiatry Neuropsychol Behav Neurol. 2001 Apr­Jun;14(2):103­8.

Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10­6.Review.

Folstein MF, Folstein SE, McHugh PR. "Mini­mental state". A practical method for grading the cognitive state of patients for the clinician. JPsychiatr Res. 1975 Nov;12(3):189­98.

Forman MS, Farmer J, Johnson JK, Clark CM, Arnold SE, Coslett HB, Chatterjee A, Hurtig HI, Karlawish JH, Rosen HJ, Van Deerlin V, Lee VM,Miller BL, Trojanowski JQ, Grossman M. Frontotemporal dementia: clinicopathological correlations. Ann Neurol. 2006 Jun;59(6):952­62.

Huey ED, Putnam KT, Grafman J. A systematic review of neurotransmitter deficits and treatments in frontotemporal dementia. Neurology. 2006Jan 10;66(1):17­22. Review.

Josephs KA, Petersen RC, Knopman DS, Boeve BF, Whitwell JL, Duffy JR, Parisi JE, Dickson DW. Clinicopathologic analysis of frontotemporaland corticobasal degenerations and PSP. Neurology. 2006 Jan 10;66(1):41­8.

Josephs KA, Duffy JR, Strand EA, Whitwell JL, Layton KF, Parisi JE, Hauser MF, Witte RJ, Boeve BF, Knopman DS, Dickson DW, Jack CR Jr,Petersen RC. Clinicopathological and imaging correlates of progressive aphasia and apraxia of speech. Brain. 2006 Jun;129(Pt 6):1385­98.Epub 2006 Apr 13.

Kertesz A, Davidson W, Fox H. Frontal behavioral inventory: diagnostic criteria for frontal lobe dementia. Can J Neurol Sci. 1997 Feb;24(1):29­36.

Kertesz A, McMonagle P, Blair M, Davidson W, Munoz DG. The evolution and pathology of frontotemporal dementia. Brain. 2005 Sep;128(Pt9):1996­2005. Epub 2005 Jul 20.

Ex. 9, page 7

EXHIBIT 10Declaration of Rachel Clattenburg

Public Citizen v. FDA et al., 16-cv-781

Ex. 10, page 1

Ex. 10, page 2

Ex. 10, page 3

James D. Neaton

1

April 2016

CURRICULUM VITAE

James D. Neaton

Name: James Dennis Neaton

Title: Professor of Biostatistics, Adjunct Professor of Medicine, Distinguished International Professor

Address: Coordinating Centers for Biometric Research

Division of Biostatistics

School of Public Health

University of Minnesota

2221 University Avenue SE, Suite 200

Minneapolis MN 55414

Education: Major Field Degree

Lamar University 1965-1968 Mathematics None

University of Minnesota 1968-1969 Biometry B.A.

School of Public Health

Biometry Division

University of Minnesota 1969-1970 Biometry M.S.

University of Minnesota 1984 Biometry Ph.D.

Honors: B.A. Awarded with Honors

Pi Mu Epsilon

Delta Omega Honorary Public Health Society

Leonard M. Schuman Excellence in Teaching Award (2001)

Fellow, American Statistical Association (1994)

Fellow, Society for Clinical Trials (2009)

Academic Health Center Academy for Excellence in Health Research (2009)

University of Minnesota Global Engagement Award (2010)

Membership in Professional Societies:

Society for Clinical Trials, President 2006-2007

Biometric Society, ENAR

American Statistical Association

American Heart Association Council on Epidemiology

International Society and Federation of Cardiology, Scientific Section on

Epidemiology and Prevention

International AIDS Society

Professional Experience:

Professor, Biostatistics Division, School of Public Health, University of Minnesota, 1995 -

present

Ex. 10, page 4

James D. Neaton

3

Principal Investigator, NIAID International Trial of IL-2 (ESPRIT), 1999- 2006.

Principal Investigator, NHLBI Extended Mortality and Follow-up and Analyses of Men in the

MRFIT, 2001 –2006.

Principal Investigator, Coordinating Center, Pharmacia/Searle CONVINCE Study, 1996 - 2004.

Director, Biostatistics Core, NCI Great Lakes Center for AIDS Research, 1998- 2003.

Principal or Co-Principal Investigator, NHLBI Multiple Risk Factor Intervention Trial (MRFIT)

Coordinating Center, 1973 - 1999.

Principal Investigator, NHLBI Mortality Surveillance of MRFIT Screenees, 1989-1999.

Co-Principal Investigator and Director of the Coordinating Center for NHLBI Treatment of Mild

Hypertension Study (TOMHS), 1985 - 1996.

Co-Investigator of primary grant and Principal Investigator of Statistical Center for a Prospective

Study of Blood Pressure and ESRD, 1991 - 1996.

Co-Principal Investigator and Director of Data Coordinating Center for NHLBI Study of

Potassium and Sodium to Control Blood Pressure in Hypertensives, 1983 - 1988.

Co-Investigator, NEI Diabetic Retinopathy Vitrectomy Study: 1975-1980

Co-Investigator, NHLBI Granulocyte Transfusion Study, 1977-1979

Editorial and Advisory Committees:

President, Society for Clinical Trials, 2006-2007

Editor in Chief, Controlled Clinical Trials, 1999-2003.

Advisory Board, Clinical Trials, 2004-2013.

Chair, Society for Clinical Trials Publication Committee, 2012 – 2014.

Chair, MRFIT Editorial Committee, 1997- 2006.

NHLBI ALLHAT External Advisory Committee, 2011-2015.

NIDDK, Diabetes Prevention Trial Outcomes Data and Safety Monitoring Board, 2011-2015.

U.S. Public Health Service - Infectious Disease Society Joint Task Force on Prevention of

Opportunistic Infection in Patients with HIV-Infection, 1994 – 2010.

U.S. Public Health Service - Panel on Clinical Practices for the Treatment of HIV Infection,

1999 - 2011.

External Advisory Committee, Institute for Clinical and Translational Research, University of

Wisconsin, 2008-2012.

Ex. 10, page 5

James D. Neaton

4

Consultant, Minimal Standards in the Prevention and Handling of Missing Data in Observational

and Experimental Patient Centered Outcomes Research, Johns Hopkins University, PCORI

contract, 2012.

External Reviewer of NHLBI Joint National Committee Report on Blood Pressure, 2012.

FDA Cardiovascular and Renal Drugs Advisory Committee, 2007- 2011.

FDA Endocrinologic and Metabolic Drugs Advisory Committee, 2014-Present.

National Academy of Sciences, Committee on National Statistics Oversight Committee for

Workshop on Handling Missing Data in Clinical Trials, 2009-2010.

FDA, Clinical Trials Transformation Initiative, Project Team for Effective and Efficient

Monitoring, 2009-2010.

NIH Director‟s Clinical Research Roadmap Meeting, 2003.

NIH Director‟s Meeting for Investigators on Open Access, 2004.

NHLBI Strategic Planning Group, 2006.

NIDDK, Extramural Advisory Committee, Special Statutory Funding Program for Type 1

Diabetes Research, 2008 and 2013

NHLBI Working Group on Clinical Use of Ventricular Assist Devices, 2008.

TrialNet External Advisory Committee, NIDDK, NIH, 2006-2011.

Consultant, South Africa PHIDISA Project, NIH, 2003 - Present.

Data Monitoring Committee, Centers for Disease Control Clinical Trials on the Treatment of

Tuberculosis, 1996 - Present.

Data Monitoring Committee, Medical Research Council, STREAM Drug Resistant TB Trial,

2014-present.

Data and Safety Monitoring Board, Bill and Melinda Gates Foundation Study of Pre-Exposure

Prophylaxis to Prevent HIV-1 Acquisition within HIV-1 Discordant Couples, 2008-2013.

Data and Safety Monitoring Board, NIAID (HPTN 039) Acyclovir for the Reduction of HIV

Acquisition, 2002 - 2008.

Data and Safety Monitoring Committee, Harvard Clinical Research Institute Dual Antiplatelet

Therapy (DAPT) Trial, 2009 - 2014.

Data and Safety Monitoring Committee, NCI, NIH Polyp Prevention Study, 2005 - 2013.

Data and Safety Monitoring Committee, Pfizer Phase 3 Program of PCSK9 Inhibition and

Reduction in Risk of Vascular Events, 2013 - present.

Ex. 10, page 6

James D. Neaton

5

Data and Safety Monitoring Board, NIDDK, NIH D2d Study of Diabetes Prevention, 2013 -

present.

Data and Safety Monitoring Board, Trevena Phase 2 Study of TRV027 for Acute Decompensated

Heart Failure, 2013 - 2015.

Data and Safety Monitoring Board, NIDDK Wisconsin Cystic Fibrosis Neonatal Screening

Project, 2003 - 2011.

Data and Safety Monitoring Board, NHLBI Systolic Blood Pressure Intervention Trial (SPRINT),

2010 - Present.

Steering Committee, Yale University Open Data Access Project (YODA), 2011 - present.

Data and Safety Monitoring Board, St. Jude Medical, Left Atrial Pressure Monitoring to Optimize

Heart Failure (LAPTOP), 2010-2014.

External Reviewer, Institute of Medicine Report, Methodological Challenges in Biomedical HIV

Prevention Trials, 2008.

Data and Safety Monitoring Board, Biocontrol, INNOVATE Heart Failure Trial, 2009-2015.

Framingham Heart Study, Observational Study Monitoring Board, NIH, NHLBI, 2001 - present.

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

Ex. 10, page 7

James D. Neaton

6

Member, DSMB, Medtronic REDUCE HF Trial, 2007 - 2009.

Advisory Committee, Inventory and Evaluation of Clinical Research Networks (IECRN), NIH

Roadmap Project, Westat, 2005-2006.

Member, DSMB, Medtronic COMPASS Heart Failure Trial, 2004-2005.

Chair, Data and Safety Monitoring Board, Merck Research Laboratories APPROVe Trial, 2001-

2004.

Chair, Data and Safety Monitoring Board, Merck Research Laboratories VIOXX Prostate Cancer

Trial and Combined Analysis of CV Events, 2003 - 2004.

Data and Safety Monitoring Board, Acorn Medical Device Trial, 2002 - 2004.

Data Monitoring Committee, Veterans Administration Trial on Varicella Vaccine for the

Prevention of Herpes Zoster and its Complications, 1999 - 2004.

Steering Committee, Searle/Pharmacia EPHESUS Study, 1999 - 2003.

NIH Gene Transfer Clinical Trials Design Working Group, 2004 - 2005.

Data and Safety Monitoring Board, St. Jude Medical Trial on SJM Regent/Epic Heart Valve, 2000

- 2006.

Data and Safety Monitoring Board, St. Jude Prospective Study of Trifecta Valve, 2007 - 2011.

Steering Committee, Merck Research Laboratories Losartan ELITE II Study, 1997 - 2000.

Data Monitoring Committee, Regeneron Pharmaceuticals Trial of r-methHuBDNF for ALS,

1998 - 2001.

Data and Safety Monitoring Committee, Merck Research Laboratories Vioxx Gastrointestinal

Outcomes Research Study (VIGOR), 1999 - 2000.

HIVNET Prevention Research Review Group, NIAID, 1995 - 1998.

Data Monitoring and Safety Committee, NICHD Maternal-Fetal Medicine Units Network,

1991 - 1996.

Data and Safety Monitoring Board, NHLBI Dietary Approaches to Stop Hypertension (DASH)

trial, 1994 - 1996.

Data and Safety Monitoring Committee, Merck Research Laboratories Losartan ELITE Study,

1994 - 1996.

(b) (4)

(b) (4)

Ex. 10, page 8

James D. Neaton

7

Data and Safety Monitoring Committee, Glaucoma Research Foundation Trial of Intraocular

pressure reduction in normal-tension glaucoma, 1996-1998.

Data and Safety Monitoring Committee, Glaxo 3TC Clinical Endpoint Protocol NUCB3007,

1995 - 1996.

Data Monitoring Board, NHLBI Prevention and Treatment of Hypertension Study, 1988 - 1994

Data and Safety Monitoring Committee, VA-NHLBI Trial of Reduction of Alcohol Intake in

Lowering Blood Pressure, 1989 - 1995

Data Monitoring Committee, NHLBI Sodium and Hypertension in Blacks, 1992 - 1995.

Data Monitoring Committee, NHLBI Women's Healthy Lifestyle Project, 1992 - 1995.

Data Monitoring Committee, NIDDK African American Study of Kidney Disease and

Hypertension, 1992 - 1994

NIH Ad Hoc Data and Safety Monitoring Review Committee on Human Growth Hormone in

Turner Syndrome, 1992 - 1993

Data Monitoring Committee, Children and Adolescent Blood Pressure Program, 1986-1990.

Special Review Committee, NCI National Bladder Cancer Project, Collaborative Group A, 1976 -

1982.

Policy Advisory Committee, NICHD Sudden Infant Death Syndrome Study, 1977 - 1984.

Participant, Keystone Dialogue (initiated by Vice-President Gore) on Establishment of Studies to

Optimize Medical Management of HIV Infection, 1996.

NIH gp160 Trial Design Team, NIAID, 1992.

Member, Joint National Committee V on Detection, Evaluation and Treatment of High Blood

Pressure (Subcommittee No. 1 on Definition, Prevalence, Evaluation, Screening and Goals

of Therapy), 1992.

Consultant, Minnesota Department of Health, Impact of Vaccination on Haemophilus Disease

Incidence, 1986 - 1992.

Consultant, Minnesota Department of Health, Smoking Cessation Protocol for Primary Care

Physician Offices, 1987 - 1990.

Seminar Committee and Faculty Member, International Teaching Seminar on Cardiovascular

Disease Epidemiology and Prevention, 1987 - 1994.

Scientific Program Committee, American Heart Association, 1984 - 1987.

Scientific Program Committee, 2nd Joint Meeting of the Society for Clinical Trials and the

International Society for Clinical Biostatistics, 1997.

Ex. 10, page 9

James D. Neaton

8

Scientific Program Committee, XIth, XIIth, XIIIth, XIVth, XVth and XIXth International

Conferences on AIDS, 1996, 1998, 2000, 2002, 2004, 2012 and 2013.

Plus ad hoc committee assignments with NIH and consultations with the Food and Drug

Administration and the pharmaceutical industry.

Appears this way on the original

Ex. 10, page 10

James D. Neaton

1

June 2014 CURRICULUM VITAE James D. Neaton Name: James Dennis Neaton Title: Professor of Biostatistics, Adjunct Professor of Medicine, Distinguished International Professor Address: Coordinating Centers for Biometric Research

Division of Biostatistics School of Public Health University of Minnesota 2221 University Avenue SE, Suite 200 Minneapolis MN 55414

Birth Date: ------------------------ Place of Birth: Galveston, Texas Citizenship: U.S.A. Education: Major Field Degree

Lamar University 1965-1968 Mathematics None

University of Minnesota 1968-1969 Biometry B.A. School of Public Health Biometry Division

University of Minnesota 1969-1970 Biometry M.S.

University of Minnesota 1984 Biometry Ph.D.

Honors: B.A. Awarded with Honors

Pi Mu Epsilon Delta Omega Honorary Public Health Society Leonard M. Schuman Excellence in Teaching Award (2001) Fellow, American Statistical Association (1994) Fellow, Society for Clinical Trials (2009) Academic Health Center Academy for Excellence in Health Research (2009) University of Minnesota Global Engagement Award (2010) Lillehei Heart Institute (2013)

Membership in Professional Societies:

Society for Clinical Trials, President 2006-2007 Biometric Society, ENAR American Statistical Association American Heart Association Council on Epidemiology International Society and Federation of Cardiology, Scientific Section on Epidemiology and Prevention International AIDS Society

Ex. 10, page 11

James D. Neaton

3

Principal or Co-Principal Investigator, NHLBI Multiple Risk Factor Intervention Trial (MRFIT) Coordinating Center, 1973 - 1999.

Principal Investigator, NHLBI Mortality Surveillance of MRFIT Screenees, 1989-1999.

Co-Principal Investigator and Director of the Coordinating Center for NHLBI Treatment of Mild

Hypertension Study (TOMHS), 1985 - 1996.

Co-Investigator of primary grant and Principal Investigator of Statistical Center for a Prospective Study of Blood Pressure and ESRD, 1991 - 1996.

Co-Principal Investigator and Director of Data Coordinating Center for NHLBI Study of

Potassium and Sodium to Control Blood Pressure in Hypertensives, 1983 - 1988.

Co-Investigator, NEI Diabetic Retinopathy Vitrectomy Study: 1975-1980

Co-Investigator, NHLBI Granulocyte Transfusion Study, 1977-1979 Editorial and Advisory Committees:

President, Society for Clinical Trials, 2006-2007 Editor in Chief, Controlled Clinical Trials, 1999-2003. Advisory Board, Clinical Trials, 2004-2013. Chair, Society for Clinical Trials Publication Committee, 2012 – present. Chair, MRFIT Editorial Committee, 1997- 2006.

NHLBI ALLHAT External Advisory Committee, 2011-present. NIDDK, Diabetes Prevention Trial Outcomes Data and Safety Monitoring Board, 2011-present. NIDDK, Vitamin D and Type 2 Diabetes Data and Safety Monitoring Board, 2013- present. U.S. Public Health Service - Infectious Disease Society Joint Task Force on Prevention of Opportunistic Infection in Patients with HIV-Infection, 1994 – 2010.

U.S. Public Health Service - Panel on Clinical Practices for the Treatment of HIV Infection,

1999 - 2011.

External Advisory Committee, Institute for Clinical and Translational Research, University of Wisconsin, 2008-2012.

Consultant, Minimal Standards in the Prevention and Handling of Missing Data in Observational

and Experimental Patient Centered Outcomes Research, Johns Hopkins University, PCORI contract, 2012.

External Reviewer of NHLBI Joint National Committee Report on Blood Pressure, 2012. Cardiovascular and Renal Drugs Advisory Committee, 2007- 2011.

Ex. 10, page 12

James D. Neaton

4

National Academy of Sciences, Committee on National Statistics Oversight Committee for Workshop on Handling Missing Data in Clinical Trials, 2009-2010.

FDA, Clinical Trials Transformation Initiative, Project Team for Effective and Efficient

Monitoring, 2009-2010. NIH Director’s Clinical Research Roadmap Meeting, 2003. NIH Director’s Meeting for Investigators on Open Access, 2004. NHLBI Strategic Planning Group, 2006. NIDDK, Extramural Advisory Committee, Special Statutory Funding Program for Type 1

Diabetes Research, 2008 and 2013 NHLBI Working Group on Clinical Use of Ventricular Assist Devices, 2008. TrialNet External Advisory Committee, NIDDK, NIH, 2006-2011. Consultant, South Africa PHIDISA Project, NIH, 2003 - Present.

Data Monitoring Committee, Centers for Disease Control Clinical Trials on the Treatment of

Tuberculosis, 1996 - Present.

Data and Safety Monitoring Board, Bill and Melinda Gates Foundation Study of Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition within HIV-1 Discordant Couples, 2008-2013.

Data and Safety Monitoring Board, NIAID (HPTN 039) Acyclovir for the Reduction of HIV

Acquisition, 2002 - 2008. Data and Safety Monitoring Committee, Harvard Clinical Research Institute Dual Antiplatelet

Therapy (DAPT) Trial, 2009 - 2014. Data and Safety Monitoring Committee, NCI, NIH Polyp Prevention Study, 2005 - 2013. Data and Safety Monitoring Committee, Pfizer Phase 3 Program of PCSK9 Inhibition and

Reduction in Risk of Vascular Events, 2013 - present. Data and Safety Monitoring Board, NIDDK, NIH D2d Study of Diabetes Prevention, 2013 -

present. Data and Safety Monitoring Board, Trevena Phase 2 Study of TRV027 for Acute

Decompenstated Heart Failure, 2013 - present. Data and Safety Monitoring Board, NIDDK Wisconsin Cystic Fibrosis Neonatal Screening

Project, 2003 - 2011. Data and Safety Monitoring Board, NHLBI Systolic Blood Pressure Intervention Trial (SPRINT),

2010 - Present. Steering Committee, Yale University Open Data Access Project (YODA), 2011 - present.

Ex. 10, page 13

James D. Neaton

5

External Data Monitoring Committee, Merck, V212, Inactivated Varicella Zoster Virus Vaccine, Studies, 2010- present.

Data and Safety Monitoring Board, Bristol-Myers Squibb I-Preserve Heart Failure Trial, 2003-

2007. Data Monitoring Committee, Astellas Phase 2 Study of ASKP1240 for Kidney Transplant

Recipients, 2013- present. Data and Safety Monitoring Board, Amgen, Etanercept in Pediatric Patients with Plaque

Psoriasis, 2004-2012. Data and Safety Monitoring Board, St. Jude Medical, Left Atrial Pressure Monitoring to

Optimize Heart Failure (LAPTOP), 2010-2014. Data and Safety Monitoring Board, Takeda, Cardiovascular outcomes in patients with type 2

diabetes, 2011-present. Data and Safety Monitoring Committee, Astra-Zeneca, Inhaled corticosteroids and serious

asthma-related events, 2011-present. Executive Committee, Phentermine/Topirmate Outcomes Trial, Vivus, 2011 - present. External Reviewer, Institute of Medicine Report, Methodological Challenges in Biomedical HIV

Prevention Trials, 2008. Data and Safety Monitoring Committee, Bristol Myers Squibb, Clinical trial of IL-6 blocker for

Crohn’s Disease, 2012-2014. Data and Safety Monitoring Board, Biocontrol, INNOVATE Heart Failure Trial, 2009-present. Framingham Heart Study, Observational Study Monitoring Board, NIH, NHLBI, 2001 - present. Steering Committee, Merck Research Laboratories Losartan HEAAL Study, 2001 - 2010. Member, DSMB, Medtronic REDUCE HF Trial, 2007 - 2009. Chair, DSMB, Merck Phase IV Clinical Trial to Evaluate the Safety and Tolerability of

ZOSTAVAX, 2007-2009 Advisory Committee, Inventory and Evaluation of Clinical Research Networks (IECRN), NIH

Roadmap Project, Westat, 2005-2006. Member, DSMB, Medtronic COMPASS Heart Failure Trial, 2004-2005. Chair, Data and Safety Monitoring Board, Merck Research Laboratories APPROVe Trial, 2001-

2004. Chair, Data and Safety Monitoring Board, Merck Research Laboratories VIOXX Prostate Cancer

Trial and Combined Analysis of CV Events, 2003 - 2004. Data and Safety Monitoring Board, Acorn Medical Device Trial, 2002 - 2004.

Ex. 10, page 14

James D. Neaton

6

Data Monitoring Committee, Veterans Administration Trial on Varicella Vaccine for the Prevention of Herpes Zoster and its Complications, 1999 - 2004.

Steering Committee, Searle/Pharmacia EPHESUS Study, 1999 - 2003. NIH Gene Transfer Clinical Trials Design Working Group, 2004 - 2005. Data Monitoring Committee, Abbott Laboratories Trial of Depakote in the Elderly, 1999 - 2002. Data and Safety Monitoring Board, St. Jude Medical Trial on SJM Regent/Epic Heart Valve,

2000 - 2006. Data and Safety Monitoring Board, St. Jude Prospective Study of Trifecta Valve, 2007 - 2011. Steering Committee, Merck Research Laboratories Losartan ELITE II Study, 1997 - 2000.

Data Monitoring Committee, Regeneron Pharmaceuticals Trial of r-methHuBDNF for ALS, 1998 - 2001.

Data and Safety Monitoring Committee, Merck Research Laboratories Vioxx Gastrointestinal

Outcomes Research Study (VIGOR), 1999 - 2000. HIVNET Prevention Research Review Group, NIAID, 1995 - 1998.

Data Monitoring and Safety Committee, NICHD Maternal-Fetal Medicine Units Network,

1991 - 1996.

Data and Safety Monitoring Board, NHLBI Dietary Approaches to Stop Hypertension (DASH) trial, 1994 - 1996.

Data and Safety Monitoring Committee, Merck Research Laboratories Losartan ELITE Study, 1994 - 1996.

Data and Safety Monitoring Committee, Glaucoma Research Foundation Trial of Intraocular

pressure reduction in normal-tension glaucoma, 1996-1998.

Data and Safety Monitoring Committee, Glaxo 3TC Clinical Endpoint Protocol NUCB3007, 1995 - 1996.

Data Monitoring Board, NHLBI Prevention and Treatment of Hypertension Study, 1988 - 1994

Data and Safety Monitoring Committee, VA-NHLBI Trial of Reduction of Alcohol Intake in

Lowering Blood Pressure, 1989 - 1995

Data Monitoring Committee, NHLBI Sodium and Hypertension in Blacks, 1992 - 1995.

Data Monitoring Committee, NHLBI Women's Healthy Lifestyle Project, 1992 - 1995.

Data Monitoring Committee, NIDDK African American Study of Kidney Disease and Hypertension, 1992 - 1994

NIH Ad Hoc Data and Safety Monitoring Review Committee on Human Growth Hormone in

Turner Syndrome, 1992 - 1993

Ex. 10, page 15

James D. Neaton

7

Data Monitoring Committee, Children and Adolescent Blood Pressure Program, 1986-1990.

Special Review Committee, NCI National Bladder Cancer Project, Collaborative Group A, 1976 -

1982.

Policy Advisory Committee, NICHD Sudden Infant Death Syndrome Study, 1977 - 1984. Participant, Keystone Dialogue (initiated by Vice-President Gore) on Establishment of Studies to

Optimize Medical Management of HIV Infection, 1996.

NIH gp160 Trial Design Team, NIAID, 1992.

Member, Joint National Committee V on Detection, Evaluation and Treatment of High Blood Pressure (Subcommittee No. 1 on Definition, Prevalence, Evaluation, Screening and Goals of Therapy), 1992.

Consultant, Minnesota Department of Health, Impact of Vaccination on Haemophilus Disease

Incidence, 1986 - 1992.

Consultant, Minnesota Department of Health, Smoking Cessation Protocol for Primary Care Physician Offices, 1987 - 1990.

Seminar Committee and Faculty Member, International Teaching Seminar on Cardiovascular

Disease Epidemiology and Prevention, 1987 - 1994.

Scientific Program Committee, American Heart Association, 1984 - 1987.

Scientific Program Committee, 2nd Joint Meeting of the Society for Clinical Trials and the International Society for Clinical Biostatistics, 1997.

Scientific Program Committee, XIth, XIIth, XIIIth, XIVth, XVth and XIXth International

Conferences on AIDS, 1996, 1998, 2000, 2002, 2004, 2012 and 2013.

Plus ad hoc committee assignments with NIH and consultations with the Food and Drug Administration and the pharmaceutical industry.

Ex. 10, page 16

Date of Preparation: 01/01/2015 ______________________________ Signature

Meera B. Chitlur, M.D.

Curriculum Vitae

OFFICE ADDRESS: HOME ADDRESS: Children's Hospital of Michigan Division of Hematology/Oncology 3901 Beaubien Blvd. Detroit, Michigan 48201 Telephone: Telephone: 313-745-5515 Fax: 313-745-5237 E-mail: mchitlur@med.wayne.edu EDUCATION: 04/1983-03/1986 MES College (Sciences & Mathematics) Bangalore, India 08/1986-04/1992 M.B.;B.S. Kempegowda Institute of Medical Science Bangalore, India POSTGRADUATE TRAINING: 07/1994 - 07/1997 Residency in Pediatrics Henry Ford Hospital, Detroit, MI 01/2001-03/2005 Fellowship in Pediatric Hematology/Oncology Children's Hospital of Michigan, Detroit, MI FACULTY APPOINTMENTS:

07/2013- Present Barnhart-Lusher Hemostasis Research Endowed Chair 06/2011- Present Associate Professor of Pediatrics, (Clinician-Educator Track) Wayne State University School of Medicine 09/2005-06/2011 Assistant Professor of Pediatrics (Clinician-Educator track) Wayne State University School of Medicine HOSPITAL OR OTHER PROFESSIONAL EMPLOYMENTS: 08/2005-current Staff Physician, Division of Hematology/Oncology University Pediatricians, P.C. 03/2005-8/2005 Research Assistant in Coagulation Division of Hematology/Oncology, Children’s Hospital of Michigan/WSU 08/1997- 12/2000 Staff Physician, Department of Pediatrics

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Platelet disorders in children.08/2009. Overview of platelet disorders and testing for platelet dysfunction for local area general pediatricians. CHM Stilson Center, Clinton Township, MI. Heavy Bleeding- a sign of something more serious? Your role in detecting Von Willebrand Disease. Sponsored by CSL Behring. Presentation on Von Willebrand Disease- clinical manifestations, pathophysiology and management for local area primary pediatricians, OBGyn and ENT physicians. 6/28/2011, Flemings Prime Steakhouse and wine bar, Livonia, MI. VWD Regional Roundtable: Case discussion with local Hemophilia Treatment Center and private hematologists on the management of patients with von Willebrand disease in the peri-operative or trauma setting. April 20th 2012, at the Sheraton Detroit Metro Airport in Romulus, Michigan. Sponsored by CSL Behring.

Media Presentations: Treatment Decisions and Clinical Outcomes in Hemophilia B with Inhibitors. This

educational initiative includes 1 CME vodcast and 1 Clinical Insight and is targeted to HEMs, HTC specialists, HTC nurses, and other clinicians interested in hemophilia treatment and management.

Dr. Meera Chitlur participated in the “VWD: Collaborate to Educate Campaign” launched

in partnership with HealthyWomen in April 2012. Media Release and Outreach – Media release distributed to more than 12,000 journalists. Pitched story to 272 print, online and broadcast journalists Radio Media Tour – Interview with Dr. Chitlur and Beth Cahill targeted radio stations in the top 50 markets Matte Release – Distributed to more than 10,000 news sources, reaching VWD patients at the grassroots level Audio News Release – Two 60-second audio packages and two 30-second PSA scripts distributed to 12,000+ local, regional and national radio stations

CONSULTING:

Selected by peers to be included in the “Best Doctors in America” database in 2007-2008, 2009-2010 and in 2011-2012. Only 5% of physicians in the United States earn this recognition. As part of this affiliation, provides consultative services for patients seeking a second opinion.

Consultant for . SCHOLARLY SERVICE: A. Service for peer reviewed journals: Manuscript review

1. J of Biomaterials Science: Polymer edition 2. Pediatric Blood and Cancer 3. Haemophilia 4. Journal of Thrombosis Hemostasis 5. Annals of Hematology 6. Thrombosis Research 7. Thrombosis and Haemostasis 8. Pediatrics in Review 9. J of the American Board of Family Medicine

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Ex. 10, page 18

B. Reviewer for the Hemophilia Thrombosis Research Society -Mentored Research Awards. C. Reviewer for NHLBI- Clinical Trials Review committee. ADVISORY BOARD MEMBER FOR: - Regional Advisory Board - Translational Advisory Board - Bleed Reduction Advisory Board GRANT SUPPORT:

A. Clinical Trials Activities Active

1. Role: PI Title: Thromboelastography in Severe Hemophilia Following Clotting Factor Replacement Therapy Sponsor: CRCM Trial Start/End Date: 2/28/2008- 12/31/2014 Funding:

2. Role: Site PI Title: Maternal and Child Health Bureau (MCHB) Comprehensive Care Grant Sponsor: MCHB Trial Start/End Date:

Funding: $46,000

3.

4. Role: Site PI

Title: My Life Our Future (MLOF) Sponsor: Biogen Idec Trial Start/Enc Date: Funding: yr 1:

5.

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Ex. 10, page 19

6. Role: Site PI for multi center trial

Title: Hemophilia inhibitor genetic study (HIGS). Sponsor: Baxter Bioscience Corp

Trial Start/End Date: 04/03-12/14 Funding:

7.

8.

9. Role: Site PI (as of 7/25/13)

Title: The Second Multicenter Hemophilia Cohort Study (MHCS-11) Sponsor: National Cancer Institute Trial Start/End Date: 9/2001 Funding:

10.

11. Role: Site PI Title: Use of rFXIII in treatment of congenital FXIII deficiency, a prospective multi-centre observational study- MENTOR 6 Sponsor: Novo Nordisk

Trial Start/End Date: 1/15/15-1/14/17 Funding:

12. Role: Site PI (as of 7/25/13) Title: Genetics of Inhibitor Formation in Hemophilia

Sponsor: Comprehensive Ctr for Bleeding Disorders-Blood Center of Southeastern Wisconsin

Trial Start/End Date: 4/2000 Funding:

13.

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Ex. 10, page 20

14.

15. Role: Co Investigator Title: Molecular and clinical biology of von Willebrand’s Disease (Zimmerman project). Source: National Institutes of Science (University of Wisconsin); Multicenter RO1 Period of Support: 06/2010 to current Direct Cost/ Indirect cost: 33,534/ 13,458

16. Role: Co Investigator Title: Comparative Effectiveness in the Diagnosis of vWD Source: National Institutes of Health, (University of Wisconsin), Multicenter RO1 Period of support: 2014- 2019 Direct Cost/Indirect Cost: $25,000/13,000 Enrolled: 25 patients

17.

18.

19.

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Ex. 10, page 21

20. Role: Co Investigator Title: Hemophilia Inhibitor Research Study Ph III (HIRS) Source: Center for Disease Control Period of Support: 2014- current Direct/Indirect costs: $20,340/16,500

21.

22.

Non-Funded Research Projects: 23. Role: PI Title: Regional and Cultural Variance in Perceptions Pertaining to Research Participation Sponsor: None Trial Start/End Date: 05/13-Current Funding: None 24. Role: Site PI

Title: Pediatric and adult intercontinental registry on chronic ITP. Sponsor: University Children’s Hospital, Basel, Switzerland

Trial Start/End Date: 4/04 to current 80 patients entered to date from our Center. Funding: None 25. Role: Site PI

Title: Is Pharmacologic intervention really required in children with ITP? Retrospective Chart Review Sponsor: None

Trial Start/End Date: 07/04-current Funding: None Completed Studies: 1. Role: Site PI for multi center trial

Title: A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency (N13 3720) (Mentor 2) Sponsor: Novo Nordisk Inc

Trial Start/End Date: 04/10- 12/14 Funding:

2. Role: Site PI for multi center trial

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Title: Prophylaxis Patient Case Collection (PRO-PACT) Sponsor: Novo Nordisk Inc

Trial Start/End Date: 4/09-05/10 Funding:

3. Role: Principal Investigator Title: Prospective ADVATE ITI Registry (Pair) Sponsor: Baxter Trial Start/End Date: 2/10 -4/11 Funding:

4. Role: Site PI for multi center trial Title: Retrospective ADVATE Immune Tolerance Induction (ITI) Registry Overview Sponsor: Baxter Bioscience Trial Start/End Date: 7/09 to 7/10 Funding: 5. Role: Site PI for multi center trial

Title: 3760- Phase 3b Trial Investigating the Pharmacokinetics & Safety Profile of Single IV Dose of rFXIII in Paediatric (1 to less than 6 Years Old) Subjects with Congenital FXIII A-Subunit Deficiency Sponsor: Novo Nordisk Inc Trial Start/End Date: 11/10-01/12 Funding:

6. Role: Site PI for multi center trial Title: Recombinant anti-hemophilic factor manufactured and formulated without added human or animal proteins (rAHF PFM): evaluation of immunogenicity, efficacy and safety in previously untreated patients with hemophilia A. (PUP study). Sponsor: Baxter Bioscience Trial Start/End Date: 4/04-09/09 Funding:

7. Role: Co-investigator Title: Prospective, Multicenter, Open Enrollment Study of Human Plasma Derived FXIII Concentrate in Subjects with Congenital Factor XIII Deficiency (Fibrogammin). Sponsor: CSL Behring Trial Start/End Date: 5/10 to 4/11 Funding:

8. Role: Co-investigator Title: Universal data and serum specimen collection (UDC) system for hemophilia. Sponsor: Centers for Disease Control (CDC) Trial Start/End Date: 06/10 to 5/11 Funding: $48,000

9. Role: Co-investigator Title: Phase 1, Prospective, Randomized, Crossover Study to Compare the Pharmacokinetics and Safety of rAHF-PFM Reconstituted in 2mL versus 5mL SWFI in Previously Treated Severe Hemophilia A Patients Sponsor: Baxter BioScience Trial Start/End Date: 2/08- 3/10 Funding:

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10. Role: Co-investigator

Title: Safety and Efficacy of N8 in prevention and treatment of bleeds in pediatric Previously treated patients with Hemophilia A Sponsor: Novo Nordisk Trial Start/End Date: 12/10 to 9/11

Funding:

11. Role: Co-investigator Title: Chiron Gene Therapy Long Term Safety Follow-up Sponsor: Chiron Corp Trial Start/End Date: 08/00 to 12/10 Funding:

12. Role: Co-investigator Title: Mechanisms of Race Based Differences in Factor VIII Immunogenicity in Hemophilia Sponsor: NIH /Supleveda Trial Start/End Date: 09/09 to 09/11 Funding: $70,000

13.

14. Role: Consultant

15.

PUBLICATIONS: Original Publications

1. Chitlur M, Bhambhani K, Mohamed AN, Ravindranath Y, Savasan S. Acute Megakaryoblastic Leukemia with a novel translocation t(17;22)(q21;q13) and synthetic liver dysfunction. Cancer Genetics and Cytogenetics 154:167-168, 2004.

2. Bakshi S, Chitlur M, Cushing B: Near-triploid acute Lymphoblastic leukemia with TEL/AML1

translocation. Indian Pediatr 41(5):493-495, 2004. ( ).

3. Chitlur M. Abella E, Singh TP, Savasan S. Severe neutropenia and thrombocytopenia following cardiac transplantation in a child. Pediatric Transplantation 9(1):94-96. 2005.

4. Lusher JM, Chitlur M: Kogenate®FS: antihemophilic factor rFVIII-FS. Therapy 3(6):699-708,

November) 2006.

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EXHIBIT 11 Declaration of Rachel Clattenburg

Public Citizen v. FDA et al., 16-cv-781

CURRICULUM VITAE Name: Suchitra Krishnan-Sarin, Ph.D. School: Yale University School of Medicine Education: B.S. Maharaja Sayajirao University of Baroda (Pharmacy) 1987 Ph.D. Purdue University (Pharmacology and Toxicology) 1992 Career/Academic Appointments: 1992-1994 Postdoctoral Fellow in Endocrinology and Metabolism, Indiana University School of Medicine,

Indianapolis, IN 1994-1996 Postdoctoral Fellow in Psychiatry, Yale University School of Medicine, New Haven, CT 1996-1998 Associate Research Scientist, Department of Psychiatry, Yale University School of Medicine 1998-2005 Assistant Professor, Department of Psychiatry, Yale University School of Medicine 2005-2015 Associate Professor, Department of Psychiatry, Yale University School of Medicine 2015- Professor, Department of Psychiatry, Yale University School of Medicine Administrative Positions: 2008-present Vice-Chair, Human Investigations Committee, Yale School of Medicine Professional Honors & Recognition 1997: Young Investigator Award, Society for Research on Nicotine and Tobacco GRANT HISTORY: Current Grants

Agency: NIDA I.D.# P50 DA036151, P50 DA036151-02S1

Title: “Yale Tobacco center of regulatory science” P.I. Suchitra Krishnan-Sarin, Ph.D. (Co-PI) Percent effort: 30% (Administrative Core); 15% (PI on Program Project; Flavor and e-

cigarette effects in adolescent smokers) Direct costs per year: $2,682,047 Total costs for project period: $20,265,754 Project period: 09/01/2013 - 08/31/2018 Agency NIH/NIAAA I.D.# R01 AA021818 (Co-PI) Title: “PET imaging of naltrexone occupancy of kappa receptors in heavy

drinkers” P.I. Suchitra Krishnan-Sarin, Ph.D.

Ex. 11, page 1

87. Hammond, C., Pilver, C.E., Rugle, L., Steinberg, M.A., Mayes, L.C., Malison, R.T., Krishnan-Sarin, S., Hoff, R.A., & Potenza, M.N. An exploratory examination of marijuana use, problem gambling severity and health correlates among adolescents. Journal of Behavioral Addictions 2014. 3(2); 90-101.

88. Leeman, R. F., Patock-Peckham, J. A., Hoff, R. A., Krishnan-Sarin, S., Steinberg, M. A., Rugle, L. J., & Potenza, M. N. Perceived parental permissibility toward gambling and risky behaviors in adolescents. Journal of Behavioral Addictions 2014. 3(2);115-23.

89. Morean, M.E., DeMartini, K., Leeman, R.F., Pearlson, G.D., Anticevic, A., Krystal, J.H., Krishnan-Sarin, S., & O’Malley, S.S. Psychometrically improved, abbreviated versions of three classic measures of impulsivity and self-control. Psychological Assessment 2014. 26(3); 1003-20

90. Larsen, H., Kong, G., Becker, D., Cousijn, J., Boendermaker, W., Cavallo, D., Krishnan-Sarin, S., & Wiers, R. Motivational processes underlying smoking in American and Dutch adolescents. Frontiers in Psychiatry 2014. 19; 5:51.

91. Camenga, D.R., Kong, G., Cavallo, D.A., Liss, A., Hyland, A., Delmerico, J., Cummings, K.M., & Krishnan-Sarin, S. Alternate tobacco product and drug use among adolescents who use electronic cigarettes, cigarettes only, and never-smokers. Journal of Adolescent Health 2014. 55(4):588-91.

92. Morean, M.E., Kong, G., Camenga, D., Cavallo, D., Connell, C. & Krishnan-Sarin, S. First drink to first drunk: quickly progressing to drinking to intoxication predicts high school student binge drinking. Alcoholism: Clinical and Experimental Research 2014. 38(10):2615-21.

93. Rahman, A. S., Balodis, I.M., Pilver, C. E., Leeman R.F., Hoff, R. A., Steinberg, M. A., Rugle, L., Krishnan-Sarin, S., & Potenza, M. N. Adolescent alcohol-drinking frequency and problem-gambling severity: adolescent perceptions regarding problem-gambling prevention and parental/adult behaviors and attitudes. Substance Abuse. 2014. 35(4):426-34.

94. Morean, M. E., Camenga, D.R., Kong, G. Cavallo, D.A., Schepis, T.S., & Krishnan-Sarin, S. Predictors of Middle School Students’ Interest in Participating in an Incentive-Based Tobacco Prevention and Cessation Program in Connecticut. Journal of Addiction 2014. 2014:915652.

95. Camenga, D.R., Kong, G., Bagot, K., Hoff, R.A., Potenza, M.N., & Krishnan-Sarin, S. Marijuana, alcohol use and attempted smoking cessation in adolescent boys and girls. Substance Abuse. 2014. 35(4):381-6.

96. Kong, G., Tsai, J., Krishnan-Sarin, S., Cavallo, D.A., Hoff, R.A., Steinberg, M.A., Rugle, L., & Potenza, M.N. A latent class analysis of pathological-gambling criteria among high-school students: Associations with gambling, risk and health/functioning characteristics. Journal of Addiction Medicine 2014. 8(6):421-30.

97. Morean, M.E., Kong, G., Camenga, D.R., Cavallo, D.A., Carroll, K.M., Pittman, B., Krishnan-Sarin, S. Contingency Management Improves Smoking Cessation Treatment Outcomes among Highly Impulsive Adolescent Smokers Relative to Cognitive Behavioral Therapy. Addictive Behaviors 2014. 42C:86-90.

98. Krishnan-Sarin, S., O'Malley, S.S., Franco, N., Cavallo, D.A., Morean, M., Shi, J., Pittman, B. & Krystal, J.H. NMDA receptor antagonism has differential effects on alcohol craving and drinking in heavy drinkers. Alcoholism: Clinical and Experimental Research. 2015. 39(2):300-7.

In-Press Peer Reviewed Manuscripts

1. Krishnan-Sarin, S., Morean, M., Camenga, D., Cavallo, D.A. & Kong, G. E-cigarette use among high school and middle school adolescents in Connecticut. Nicotine and Tobacco Research.

2. Kong, G., Morean, M., Cavallo, D.A., Camenga, D.R., & Krishnan-Sarin, S. Reasons for experimentation and discontinuation of e-cigarette use among adolescents and young adults. Nicotine & Tobacco Research.

Ex. 11, page 2

Ex. 11, page 3

Receptors and Antagonists: From Bench to Clinic. R. Humana Press, Totowa, NJ. 10. Smith, A. E. & Krishnan-Sarin, S. (2009). Tobacco and Nicotine Dependence. In: Grant, J.E., and

Potenza, M.N. (eds) Textbook of Young Adult Mental Health, Oxford University Press, New York, NY. 11. Krishnan-Sarin, S., Rounsaville, B. J., & O’Malley, S.S. (2009). Opioid receptor antagonists:

Naltrexone and Nalmefene. In: Sadock, B.J., Sadock, V.A., Ruiz, P. (eds) Comprehensive Textbook of Psychiatry/9th edition, Williams and Wilkins, New York.

12. Muvvala, S., Krishnan-Sarin, S., & O’Malley, S.S. (2016). Opioid receptor antagonists: Naltrexone and Nalmefene. In: Sadock, B.J., Sadock, V.A., Ruiz, P. (eds) Comprehensive Textbook of Psychiatry/10th edition, Williams and Wilkins, New York.

Ex. 11, page 4

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A. CATHARINE ROSS CURRICULUM VITAE PRESENT POSITION: Professor of Nutrition, Occupant, Dorothy Foehr Huck Chair,

Department of Nutritional Sciences, Pennsylvania State University Work address: 110/204 Chandlee Building University Park, PA 16802 Office phone: (814) 865-4721/Fax: 814 863-6103 E-mail: acr6@psu.edu EDUCATION B.S. 1970 University of California at Davis; (College of Letters and Sciences,

major in zoology) M.N.S. 1972 Cornell University, Graduate School of Nutrition, (College of

Agriculture and Life Sciences, emphasis in nutritional biochemistry)

Ph.D. 1976 Cornell University, Department of Biochemistry, Molecular and

Cell Biology (graduate advisor , Ph.D.) Post-doctoral Columbia University, Department of Medicine, Division of 1976-78 Metabolism and Nutrition [preceptor M.D.] PREVIOUS POSITIONS HELD 1978-1982 Assistant Professor of Biochemistry, Department of Physiology

and Biochemistry, Medical College of Pennsylvania Assistant Professor of Pediatrics (Nutrition), Department of

Pediatrics, Medical College of Pennsylvania 1983-1989 Associate Professor of Biochemistry, Department of Physiology

and Biochemistry, Medical College of Pennsylvania Spring 1982 Visiting Scientist, Institute of Nutrition Research, University of

Oslo, Oslo, Norway 1989-1994 Professor of Biochemistry, Department of Biochemistry (known as

Department of Physiology and Biochemistry prior to 1992) 1991-1994 Professor of Pediatrics (Nutrition), Department of Pediatrics 1986-1994 Director, Division of Nutrition, Medical College of Pennsylvania 1991-1993 Director of Graduate Training, Department of Biochemistry,

Medical College of Pennsylvania

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Leukocyte Biology; Journal of Infectious Diseases; Journal of Lipid Research; Journal of Nutrition; Journal of Pediatrics; Pediatric Research; Nutrition Research; Proceedings of the National Academy of Sciences (USA), Translational Research.

PUBLICATIONS

Ross, AC, Zilversmit DB, Disposition of plasma cholesterol in the pregnant hypo-cholesterolemic rabbit. Am. J. Physiol. 230: 754-761, 1976.

Ross AC, Zilversmit DB, Chylomicron remnant cholesteryl esters as the major constituent of very low density lipoproteins in plasma of cholesterol-fed rabbits. J. Lipid Res. 18: 169-181, 1977.

Ross AC, Zilversmit DB, Use of esterified retinol to trace the degradation of chylomicrons in cholesterol-fed rabbits. In: Atherosclerosis, G. W. Manning and D. M. Haust, eds., Plenum Press, New York, pgs. 142-145, 1977.

Ross AC, Minick CR, Zilversmit DB, Equal atherosclerosis in rabbits fed cholesterol-free, low-fat diet or cholesterol-supplemented diet. Atherosclerosis 29: 301-315, 1978.

Ross AC, Takahashi Y, Goodman DS, The binding protein for retinol from rat testis cytosol: isolation and partial characterization. J. Biol. Chem. 253: 6591-6598, 1978.

Ross AC, Goodman DS, Intracellular binding proteins for retinol and retinoic acid: comparison with each other and with serum retinol-binding protein. Fed. Proc. 38: 2515-2518, 1979.

Ross AC, Adachi N, Goodman DS, The binding protein for retinoic acid from rat testis cytosol: isolation and partial characterization. J. Lipid Res. 21; 100-108.

Ross AC, Separation of long-chain fatty acid esters of retinol by high-performance liquid chromatography. Anal. Biochem. 115: 324-330, 1981.

Ross AC, Retinol esterification by mammary gland microsomes from the lactating rat. J. Lipid Res. 23: 133-144, 1982.

Ross AC, Retinol esterification by rat liver microsomes. Evidence for a fatty acyl-CoA: retinol acyltransferase. J. Biol. Chem. 257: 2453-2459, 1982.

Ross AC, Go K, Heider J, Rothblat GH, Selective inhibition of acyl-coenzyme A: cholesterol acyltransferase by compound 58-035. J. Biol. Chem. 259: 815-819, 1984.

Ross AC, and J. F. Rowe, Cholesterol esterification by mammary gland microsomes from the lactating rat. Proc. Soc. Exp. Biol. Med. 176: 42-47, 1984.

Davila ME, Norris L, Cleary MP, Ross AC, Vitamin A during lactation: relationship of maternal diet to milk vitamin A content and to the vitamin A status of lactating rats and their pups. J. Nutr. 115: 1033-1041, 1985.

Ex. 11, page 8

Zolfaghari R, Ross AC. Hepatocyte nuclear factor 4α (HNF4α) in coordination with retinoic acid receptors increases CYP26A1 expression in hepatocytes. J. Cell. Biochem. E-pub May 12, 2014.

Tan LT, Wray AE, Green MH, Ross AC, Compartmental modeling of whole-body vitamin A kinetics in unsupplemented and vitamin A-retinoic acid supplemented neonatal rats. J Lipid Res E-pub Jun 9, 2014.

In press

Submitted

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.

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1

Scott Richard Evans January, 2016

Center for Biostatistics in AIDS Research (CBAR)

Department of Biostatistics

Harvard T.H. Chan School of Public Health (HSPH)

651 Huntington Avenue (FXB-625A)

Boston, MA 02115

Tel: 432-2998

FAX: 432-3163

Email: evans@sdac.harvard.edu

http://www.hsph.harvard.edu/research/scott-evans/

EDUCATION

Ph.D. Biostatistics University of Massachusetts

M.S. Mathematics University of New Hampshire

B.S. Mathematics Plymouth State College

ACADEMIC APPOINTMENTS

Primary Appointments

2007-present Senior Research Scientist, CBAR, Department of Biostatistics, HSPH

2002-2006 Research Scientist, CBAR, Department of Biostatistics, HSPH

2000-2001 Research Associate, CBAR, Department of Biostatistics, HSPH

Secondary Appointments

2010-present Professor, Department of Biostatistics and the Center for Advanced Medical

Engineering and Informatics, Osaka University, Japan

CURRENT RESEARCH SUPPORT

2013-present Statistical and Data Management Center (SDMC), Antibacterial Resistance

Leadership Group (ARLG), NIAID (Evans, HSPH PI)

2013-present Biostatistics Training in the NeuroAIDS Research Training Program, Fogarty

(Evans, HSPH PI)

RESEARCH INTERESTS

Design, Monitoring, Analyses, and Reporting of Clinical Trials

Antibiotic Resistance

Benefit:risk Analyses

Education

Ex. 11, page 10

8

PUBLICATIONS

Refereed Journals

1. Robertson K, Jiang H, Evans SR, Marra CM, Berzins B, Hakim J, Sacktor N, Silva MT,

Campbell TB, Nair A, Schouten J; With the 5271 study team, Kumwenda J,

Supparatpinyo K, Tripathy S, Kumarasamy N, la Rosa A, Montano S, Mwafongo A,

Firnhaber C, Sanne I, Naini L, Amod F, Walawander A; AIDS Clinical Trials Group. J

Neurovirol. 2016.

2. Hauck C, Cober E, Richter S, Perez F, Salata R, Kalayjian R, Watkins R, Scalera N, Doi

Y, Kaye K, Evans SR, Fowler V, Bonomo R, van Duin D. Spectrum of Excess Mortality

due to Carbapenem-Resistant Klebsiella pneumoniae Infections. Clinical Microbiology

and Infection. 2016.

3. Evans SR and Follmann D. Fundamentals and Innovation in Antibiotic Trials. Statistics

in Biopharmaceutical Research. 7:4, 331-336, DOI:10.1080/19466315.2015.1094406.

2015.

4. Evans SR, Rubin D, Follmann D, Pennello G, Huskins WC, Powers JH, Schoenfeld D,

Chuang-Stein C, Cosgrove SE, Fowler Jr. VG, Lautenbach E, Chambers HF. Desirability

of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk

(RADAR). CID. 61, 800–806. 2015.

5. Evans SR, Hujer AM, Jiang H, Hujer KM, Hall T, Marzan C, Jacobs MR, Sampath R,

Ecker DJ, Manca C, Chavda K, Zhang P, Fernandez H, Chen L, Mediavilla JR, Hill CB,

Perez F, Caliendo A, Fowler Jr. VG, Chambers HF, Kreiswirth BN, and Bonomo RA.

Rapid Molecular Diagnostics, Antibiotic Treatment Decisions, and Developing

Approaches to Inform Empiric Therapy: PRIMERS I and II. CID. DOI:

10.1093/cid/civ837. 2015.

6. Uno H, Wittes J, Fu H, Solomon SD, Claggett B, Tian L, Cai T, Pfeffer MA, Evans SR,

Wei LJ. Alternatives to hazard ratios for comparing efficacy or safety of therapies in

noninferiority studies. Annals of Internal Medicine. doi:10.7326/M14-1741. 2015.

7. Ando Y, Hamasaki T, Evans SR, Asakura K, Sugimoto T, Sozu T, Ohno Y. Sample size

considerations in clinical trials when comparing two interventions using multiple co-

primary binary relative risk contrasts. Statistics in Biopharmaceutical Research. 2015.

8. Hamasaki T, Asakura K, Evans SR, Sugimoto T, Suzo T. Group-sequential Strategies in

Clinical Trials with Multiple Co-primary Outcomes. Statistics in Biopharmaceutical

Research. 2015.

9. Ochiai T, Hamasaki T, Evans SR, Asakura K,Ohno Y. Group-sequential three-arm

noninferiority clinical trial designs. Journal of Biopharmaceutical Statistics. 2015.

10. van Duin D, Cober E, Richter S, Perez F, Kalayjian R, Salata R, Evans SR, Fowler V,

Kaye K, Bonomo R. Impact of Therapy and Strain Type on Outcomes in Urinary Tract

Infections Caused by Carbapenem-Resistant Klebsiella pneumonia. Journal of

Antimicrobial Therapy. 2015.

11. van Duin D, Cober E, Richter S, Perez F, Kalayjian R, Salata R, Evans SR, Fowler V,

Bonomo R, Kaye K. Residence in Skilled Nursing Facilities is Associated with

Tigecycline Non-Susceptibility in Carbapenem-Resistant Klebsiella pneumonia. Infection

Control and Hospital Epidemiology. 2015.

12. Messina JA, Cober E, Richter SS, Perez F, Salata RA, Kalayjian RC, Watkins RR,

Scalera NM, Doi Y, Kaye KS Evans SR, Bonomo RA, Folwer Jr VG, van Duin D.

Hospital Readmissions in Patients with Carbapenem-Resistant Klebsiella pneumonia. Infection Control and Hospital Epidemiology. 2015.

13. Lee A, Bosch RJ, Evans SR, Wu K, Harrison T, Grant P, Clifford DB. Patterns of

peripheral neuropathy in ART-naïve patients initiating modern ART regimen. Journal of

NeuroVirology. 2015.

Ex. 11, page 11

14

88. Swindells S, Evans SR, Zackin R, Goldman M, Haubrich R, Filler SG, Balfour Jr, HH.

Predictive Value of HIV-1 Viral Load on Risk for Opportunistic Infection. JAIDS,

30:154-158, 2002.

89. Chung RT, Evans SR, Yang Y, Dickens T, Valdez H, Clark R, Shikuma C, Nevin T,

Sherman K. Immune Recovery is Associated with Persistent Rise in HCV RNA,

Infrequent Liver Test Flares, and is Not Impaired by HCV in Coinfected Subjects. AIDS,

16:1915-1923, 2002.

90. Buonaccorsi JP, Elkinton JS, Evans SR, Liebhold AM. Measuring and Testing for

Spatial Synchrony. Ecology, 82(6), pp. 1668-1679, 2001.

Textbooks

1. Evans SR and Ting, N. Fundamental Concepts for New Clinical Trialists. ISBN

9781420090871 - CAT# C9087. Chapman & Hall/CRC Biostatistics Series. 2015.

2. Sozu T, Hamasaki T, Sugimoto T, Evans SR. Sample size determination in clinical trials

with multiple endpoints. ISBN 978-3-319-22005-5. Springer. 2015.

3. Evans SR,

.

Book Chapters

1. Jiang Q, Ma H, Chuang-Stein C, Evans SR, He W, Quartey G, Scott J, Wen S, Arani R.

Understanding and Evaluating Uncertainties in the Assessment of Benefit-Risk in

Pharmaceutical Drug Development. Benefit-Risk Assessment Methods in Medicinal

Product Development: Bridging Qualitative and Quantitative Assessments. CRC Press

Taylor & Francis Group. 2016.

2. Wen S, He W, Evans SR, Ma H, Chuang-Stein C, Jiang Q, Li X, Quartey G, Arani R.

Visualization of Benefit-Risk Assessment in Medicinal Products with Real Examples.

Benefit-Risk Assessment Methods in Medicinal Product Development: Bridging

Qualitative and Quantitative Assessments. CRC Press Taylor & Francis Group.

2016. 3. He W, Bloomfield D, Mai Y, Evans SR. Practical Considerations for Benefit Risk

Assessment and Implementation: Vorapaxar TRA-2P TIMI 50 Case Study. Benefit-Risk

Assessment Methods in Medicinal Product Development: Bridging Qualitative and

Quantitative Assessments. CRC Press Taylor & Francis Group. 2016.

Letters

1. Evans, SR. Editors Letter. CHANCE 27:2:2016.

2. Evans, SR. Editors Letter. CHANCE 27:1:2016.

3. Evans SR, Follmann D, Schoenfeld D, Chambers HF. Response to Phillips et.al. CID.

2015.

4. Evans, SR. Editors Letter. CHANCE 27:4:2015.

5. Evans, SR. Editors Letter. CHANCE 27:3:2015.

6. Evans, SR. Editors Letter. CHANCE 27:2:2015.

7. Evans, SR. Editors Letter. CHANCE 27:1:2015.

8. Evans, SR. Editors Letter. CHANCE 27:4:2014.

9. Evans, SR. Editors Letter. CHANCE 27:3:2014.

10. Evans, SR. Editors Letter. CHANCE 27:2:2014.

11. Evans, SR. Editors Letter. CHANCE 27:1:2014.

(b) (4)(b) (4)

Ex. 11, page 12

Mara L. Becker, M.D., M.S.C.E. 5415 Locust Street

Kansas City, MO 64110 (816) 234-3686 (816) 302-9962

mlbecker@cmh.edu

Education Fellow, Clinical Pharmacology, Children’s Mercy Hospitals and Clinics

Masters of Science in Clinical Epidemiology, University of Pennsylvania, Philadelphia, PA

Fellowship in Pediatric Rheumatology, Thomas Jefferson University/Nemours Foundation, DuPont Hospital for Children, Wilmington, DE

Residency in Pediatrics, Thomas Jefferson University/Nemours Foundation, DuPont Hospital for Children, Wilmington, DE

M.D., Jefferson Medical College, Philadelphia, PA

B.A. in General Arts and Sciences, Minor in Art History (with Distinction), Pennsylvania State University, State College, PA

2009-2012 2004-2007 2003-2006 1999-2003 1995-1999 1990-12/1994

Appointments Associate Professor Department of Pediatrics University of Missouri at Kansas City Children’s Mercy Hospital 2401 Gillham Rd Kansas City, MO, 64108 Assistant Professor Department of Pediatrics University of Missouri at Kansas City Children’s Mercy Hospital 2401 Gillham Rd Kansas City, MO, 64108 Chief Resident Department of Pediatrics Thomas Jefferson University/ duPont Hospital for Children Wilmington, DE

July 2011 2006-June 2011 2002-2003

Other Positions and Employment Division Director, Rheumatology Children’s Mercy, Kansas City

January 2013-current

Certification and Licensure Certification in Pediatric Rheumatology Certification in General Pediatrics

USMLE Step 3 USMLE Step 2 USMLE Step 1 Medical License, State of Kansas (#04-31860) Medical License, State of Missouri (# 2006016507)

2006 2002, 2012 2000 1998 1997 2006 2006

Ex. 11, page 13

Journals: Respiration Pediatrics Clinical Pharmacology and Therapeutics Journal of Rheumatology Current Drug Safety Pharmacogenetics and Genomics Medical Science Monitor Arthritis Care and Research British Journal of Dermatology British Journal of Pharmacology Arthritis and Rheumatology

2007 2009-current 2010-current 2010-current 2010-current 2010-current 2010-current 2012-current 2013-current 2015-current 2015-current

Abstracts and Presentations

Oral Presentations National/International Meetings

Kessler EA, Smith C, Anderson R, Becker M. Cost of Care Associated With Pediatric Rheumatology Clinic Visits and Interest in Telemedicine. American Telemedicine Association Conference, Los Angeles, CA, May 5, 2015

van Haandel L Funk RS, Ibarra MI, Hoeltzel MF, Lasky A, Dai D, Gaedigk R, Leeder JS, Becker ML Degree of Initial Intracellular Folate Depletion May Predict Methotrexate Response in Juvenile Idiopathic Arthritis American College of Rheumatology annual meeting, Washington, DC November 14, 2012 Fox, E Gibson M, Zhang LQ, Ye SQ, Leeder JS, Becker ML Decreased Expression of Nicotinamide Phosphoribosyltransferase (NAMPT) in Active Juvenile Idiopathic Arthritis Patients Receiving Methotrexate. American College of Rheumatology annual meeting, Chicago November 6, 2011 Patel D Newell B, Becker ML. 9 day old infant with oral ulcerations, fever and irritability. Case of the year presentation at Society for Pediatric Dermatology meeting, July, 2011 Poola A vanHaandel L, Gaedigk R, Talib N, Leeder JS, Becker ML. Intracellular Folate Concentration and Polyglutamate Distribution in Down Syndrome, Pediatric Academic Society Meeting, Denver Colorado, May 2, 2011 Bi C., Becker ML, Leeder JS. Derivation of Minimum Best Sample Size from Microarray Data Sets: A Monte Carlo Approach. IEEE CIBCB, 2011 Symposium on Computational Intelligence in Bioinformatics and Computational Biology, Paris France Finkel T, Zhang H, Lie B, Becker, ML, et al. Discovery and Replication of JIA Predisposition Genes by Genome-Wide Association and Validation of Candidates in Fibroblast-Like Synoviocytes, ACR academic meeting, Atlanta, November, 2010 Becker ML, Gaedigk R, van Haandel L, et al. Folate Pathway Genes that Predict Methotrexate Polyglutamate Patterns and Response in Juvenile Idiopathic Arthritis, 4th Annual Translational Research in Pediatric Rheumatology (TRiPR) meeting, Genoa Italy, May 27, 2010 Becker ML, Gaedigk R, van Haandel L, et al. Genetic Predictors of Methotrexate

2015 2012 2011 2011 2011 2011 2010 2010 2010

(b) (6)

(b) (6)

(b) (6)

(b) (6)

(b) (4)

Ex. 11, page 14

Ex. 11, page 15

Yusef Sayeed, MD, MPH, MEng, CPH

EDUCATION AND TRAINING

INSTITUTION AND LOCATION DEGREE (if applicable) YEAR(s) FIELD OF STUDY

University of Louisville, Louisville KY

B.S.E.C.E. 2001 Electrical Engineering University of Louisville, Louisville KY M.Eng. 2003 Electrical Engineering University of Kentucky, Lexington KY M.P.H. 2004 Health Services Admin. University of Kentucky, Lexington KY M.D. 2009

Medicine Mayo Clinic, Rochester MN University of Pennsylvania, Philadelphia PA West Virginia University, Morgantown WV

2010 2011

2014-2016

Sports Medicine Resident Physician, Intern Resident Physician (Chief)

Professional Experience: 5/00-8/01 Engineering Cooperative Internship, Raytheon Company Louisville, KY Duties: Production Support of Phalanx Gun System Final Testing and Acceptance; design of Thermal Imaging Test Set Major Subsystem Design and Analysis including High voltage and Electro-Mechanical Systems 8/01-4/02 Part-Time Supervisor Plant Engineering, United Parcel Service Louisville, KY Duties: Managed approximately twelve employees in Housekeeping duties. Also, I have had contract experience and negotiation with regards to Union Employees. Maintenance duties including Load Belts and PLC work 5/04-8/04 Assistant to the Commissioner, KY Commissioner of Public Health Frankfort, KY Duties: Worked with the State public health office in developing an emergency communication system. Worked with Emergency coordination facilities across the state to improve disaster response and communications 10/14-6/15 Guest Researcher, CDC-National Institute of Occupational Safety and Health Morgantown, WV Duties: Division of Safety Research, Fatality Assessment and Control Evaluations, Tree trimmer fatality assessments, Internal FACE report reviewer evaluating worker fatalities in 18 states. Contributing author for NIOSH’s response to OSHA’s request for comments on Cell phone tower worker safety. 11/15-12/15 Resident, Occupational Safety and Health Administration, US Department of Labor Washington, DC Duties: Division of Occupational Medicine: Case evaluation, medical record review, conduct employee interviews and medical screening activities in support of work site inspection activities. Provided Expert opinions regarding whether injuries/illnesses and fatalities are related to work and determine whether employers are in compliance with medical surveillance and recordkeeping requirements of OSHA standards and regulations. Teaching Experience:

2000-2003 Instructor, Beginning Algebra, Intermediate, and College Algebra UofL/Kentucky Community and Technical Colleges Louisville, KY

Ex. 11, page 16

Ex. 11, page 17

EXHIBIT 12 Declaration of Rachel Clattenburg

Public Citizen v. FDA et al., 16-cv-781

Curriculum Vitae and Bibliography Kimberly K. Amrami, MD

PERSONAL INFORMATION

Citizenship:

Work Address:

Mayo Clinic 200 First Street SW Rochester, MN 55905 507-284-1728

Email Address:

amrami.kimberly@mayo.edu

PRESENT ACADEMIC RANK AND POSITION

Consultant - Department of Radiology, Mayo Clinic, Rochester, Minnesota

10/14/2001 - Present

Master's Faculty Privileges in Clinical & Translational Science - Mayo Graduate School, Mayo Clinic College of Medicine

06/11/2007 - Present

Consultant (Joint Appointment) - Department of Neurologic Surgery, Mayo Clinic, Rochester, Minnesota

04/09/2008 - Present

Professor of Radiology - Mayo Clinic College of Medicine

01/01/2009 - Present

Chair - Division of Musculoskeletal Radiology, Department of Radiology, Mayo Clinic, Rochester, Minnesota

06/05/2013 - Present

Consultant - Division of Musculoskeletal Radiology, Department of Radiology, Mayo Clinic, Rochester, Minnesota

06/05/2013 - Present

EDUCATION

University of Minnesota BA, Hebrew Language and Literature

1973 - 1978

University of Minnesota BS, Secondary Education with Elementary Endorsement

1983 - 1984

University of Minnesota MD

1989 - 1993

University of Minnesota Resident, Diagnostic Radiology

1993 - 1997

Mayo Clinic in Rochester Fellow, Musculoskeletal Radiology

1997 - 1998

CERTIFICATION(S) Board Certification(s)

American Board of Radiology

Diagnostic Radiology

1997 - Present

National Board of Medical Examiners (NBME)

Diplomate

1994 - Present

(b) (6)

Ex. 12, page 1

BIBLIOGRAPHY Peer-reviewed Articles

1. Garfinkel BD, Amrami KK. Assessment and differential diagnosis of attention deficit-hyperactivity

disorder. Child Adolesc Psychiatr Clin N Am. 1992; 1(2):311-423.

2. Garfinkel BD, Amrami KK. A perspective on the attention-deficit disorders. Hospital & Community Psychiatry. 1992 May; 43(5):445-6, 448. PMID:1587505.

3. Latchaw RE, Remley KB, Amrami KK. Diagnostic imaging of the brain stem. Neurosurg Clin N Am. 1993 Jul; 4(3):433-56. PMID:8353443.

4. du Cret RP, Haidet GC, Amrami KM, Boudreau RJ, Kuni CC. Factors affecting data acquisition during gated radionuclide ventriculography. Semin Nucl Med. 1994 Jan; 24(1):81-3. PMID:8122131.

5. *Baraga JJ, Amrami KK, Swee RG, Wold L, Unni KK. Radiographic features of Ewing's sarcoma of the bones of the hands and feet. Skeletal Radiol. 2001 Mar; 30(3):121-6. PMID:11357448.

6. Boon AJ, Smith J, Zobitz ME, Amrami KM. Snowboarder's talus fracture. Mechanism of injury. Am J Sports Med. 2001 May-Jun; 29(3):333-8. PMID:11394605.

7. Amrami KK, Sperling JW, Bartholmai BJ, Sundaram M. Radiologic case study - Glenolabral articular disruption (GLAD) lesion. Orthopedics. 2002 Jan; 25(1):29, 95-6. PMID:11811238.

8. Lauder TD, Stuart MJ, Amrami KK, Felmlee JP. Exertional compartment syndrome and the role of magnetic resonance imaging. American Journal of Physical Medicine & Rehabilitation. 2002 Apr; 81(4):315-9. PMID:11953551.

9. Kocharian A, Adkins MC, Amrami KK, McGee KP, Rouleau PA, Wenger DE, Ehman RL, Felmlee JP. Wrist: improved MR imaging with optimized transmit-receive coil design. Radiology. 2002 Jun; 223(3):870-6. PMID:12034961.

10. Amrami KK, Savcenko V, Dahm DL, Sundaram M. Radiologic Case Study. Reverse Bankart lesion with posterior labral tear. Orthopedics. 2002 Jul; 25(7):720, 779-80. PMID:12138956.

11. Amrami KK, Askari KS, Pagnano MW, Sundaram M. Radiologic Case Study - Abrasion chondroplasty mimicking avascular necrosis. Orthopedics. 2002 Oct; 25(10):1018, 1107-8. PMID:12401005.

12. Amrami KK, Sundaram M. Radiologic case study. Orthopedics. 2002 Dec; 25(12):1344, 1431-1432. PMID:12502195.

13. *Itoi E, Lee SB, Amrami KK, Wenger DE, An KN. Quantitative assessment of classic anteroinferior bony Bankart lesions by radiography and computed tomography. Am J Sports Med. 2003 Jan-Feb; 31(1):112-8. PMID:12531767.

14. Amrami KK, Sundaram M, Shin AY, Bishop AT. Mycobacterium marinum infections of the distal upper extremities: clinical course and imaging findings in two cases with delayed diagnosis. Skeletal Radiol. 2003 Sep; 32(9):546-9. Epub 2003 May 28. PMID:12774175. DOI:10.1007/s00256-003-0643-z.

15. *Jones TP, Beckenbaugh JP, Sperling JW, Amrami KK, Sundaram M. Radiologic case study - Posterior shoulder dislocation. Orthopedics. 2003 Jul; 26(7):682, 745-6. PMID:12875560.

Ex. 12, page 2

69. *Koff MF, Amrami KK, Felmlee JP, Kaufman KR. Variation in T2 values related to method of calculation: implications for correlative and longitudinal studies. Meeting of International Magnetic Resonance Imaging in Medicine (ISMRM) Berlin, Germany, 2007 May:2617.

70. Dyck PJB, Spinner RJ, Amrami KK, Klein CJ, Engelstad JK, Dyck PJ. Targeted fascicular biopsy of proximal nerves with MRI abnormality may be diagnostically informative. J Peripher Nerv Syst. 2007 Jul; 12(Suppl 1):27-8.

71. Mauermann ML, Dyck PJ, Kuntz NL, Amrami KK, Spinner RJ, Bosch EP, Engelstad JK, Dyck PJB. Perineurioma: A focal, motor predominant, benign nerve tumor of the young. J Peripher Nerv Syst. 2007 Jul; 12(Suppl 1):57-8.

72. Taghavi V, Dyck PJ, Spinner RJ, Amrami KK, Kurtin PJ, Engelstad JK, Dyck PJB. Clinical and neuropathological characteristics of peripheral nerve lymphoma. J Peripher Nerv Syst. 2007 Jul; 12(Suppl 1):85.

73. *Anderson ML, Larson AN, Skinner J, Berger R, Amrami KK. Quantification of Radial Torsion Angle with Computerized Tomography: A Clinical Comparison. Radiological Society of North America. 2007 Nov(LL-MK4145-H05):881.

74. *Anderson ML, Felmlee JP, Berger R, Amrami KK. Diagnostic Comparison of 1.5T and 3.0T Preoperative MRI of the Wrist in Patients with Ulnar Sided Wrist Pain. Radiological Society of North America. 2007 Nov(LL-MK4153-L06):883.

75. Kermani T, Moder KG, Amrami K, Berry D, Crowson C. Clinical characteristcs of patients with Systemic Lupus Erythematosus and Avascular Necrosis. Americal College of Rheumatology. 2008.

76. *Summers HG, Spinner RJ, Nathan M, Anderson M, Felmlee JP, Amrami KK. Metastatic or Recurrent Breast Cancer to the Brachial Plexus: MR Imaging Characteristics with PET and Clinical Correlation. International Society of Magnetic Resonance in Medicine 16th Scientific Meeting and Exhibition. 2008.

77. Amrami KK. 3-T Musculoskeletal Imaging Small Joint Imaging at 3.0T. RSNA. 2008.

78. Nagata S, Stanley DW, Williams SL, Wood MM, Felmlee JP, Nishimura H, Hayabuchi N, Amrami KK. Feasibility of Magnetization Transfer Ration of the Patellar Articular Cartilage at 3T. Internation Society for Magnetic Resonance in Medicine. 2009.

79. Amrami KK. Unsolved Problems in MSK MR: Clinical Wrist Abnormalities Not Detectable on MR Imaging. International Society for Magnetic Resonance in Medicine. 2009.

80. Nagata S, Stanley DW, Williams SL, Wood MM, Hong SJ, Felmlee JP, Amrami KK. Assessment of Magnetization Transfer Ratio, Diffusion Weighted Image, and T2-Weighted Image in Human Median Nerve at 3T: Comparison with Carpal Tunnel Syndrome. International Society for Magnetic Resonance in Medicine. 2009.

81. Nagata S, Amrami KK, Robert SK, Laack NN, Inwards C, Wenger DE. Chondroid Lesions. Journal of the ISS. 2009.

82. Ehman EC, Hayes ML, Amrami KK, Berger R, Felmlee JP. Measurement of Subluxation of the Distal Radio-ulnar Joint as a Predictor of Triangular Fibrocartilage Tears. Radiological Society of North America. 2009.

Ex. 12, page 3

83. Nagata S, Amrami KK, Stanley D, Wood M, Felmlee JP, Uchida M. Magnetization Transfer Ratio of the Patellar Articular Cartilage at 3T: Correlation with Clinical Findings and BMI. Radiological Society of North America. 2009.

84. Woodrum DA, Amrami KK, Gorny K, Felmlee JP, Atwell TD, Schmit GD, Kawashima A, Mynderse LA, Callstrom M. Feasibility of 3.0T MRI-Guided Laser Ablation of a Cadaveric Prostate. RSNA. 2009.

85. Mynderse L, Kawashima A, Callstrom M, Gorny K, Atwell T, McPhail F, Amrami K, Woodrum D. MRI-Guided Trans-perineal Laser Ablation of Locally Recurrent Prostate Adenocarcinoma Following Radical Prostatectomy. Society of Urologic Oncology. 2009 Sep.

86. Woodrum D, Schmit G, Hartman R, Atwell T, Gorny K, Amrami K, Mcphail E, Bolster B, Bjaranson H, Mynderse L, Callstrom M, Kawashima A. MR-Guided Trans-perineal Cryoablation of Locally Recurrent Prostate Adenocarcinoma Following Radical Retropubic Prostatectomy (RRP). Abdominal Radiology Course. 2010 Feb.

87. Mauermann ML, Scheithauer B, Spinner RJ, Amrami KK, Kline D, Tiel R, Dyck PJ, Nance C, Engelstad J, Dyck PJB. Clinical characteristics and potential therapeutic implications of inflammatory pseudomotor of nerve. Neurology. 2010 Mar; 74(9 Suppl 2):A528.

88. Stanley DW, Shahid KR, Felmlee JP, Amrami KK, Han ET, Rettmann DW. Quantitative Reproducibility Initial Study of T1 Rho at 3T. International Society of Magnetic Resonance in Medicine. May 2010.

89. Dyck PJB, Massie R, Mauermann ML, Amrami KK, Mandrekar J, Dyck PJ. Diabetic cervical radiculoplexus neuropathy: natural history and pathology of a distinct syndrome. J Peripher Nerv Syst. 2011 Sep; 16(3):S31.

90. Dyck PJB, Staff NP, Engelstad JK, Klein CJ, Amrami KK, Spinner RJ, Dyck PJ, Warner MA, Warner ME. Post-surgical inflammatory neuropathy. J Peripher Nerv Syst. 2011 Sep; 16(3):S31-2.

91. Reddy C, Mauermann M, Begna K, Ringler M, Jerath N, Amrami K, Spinner R. Leukemic infiltration of peripheral nerve: case series and review of the literature. Neurology. 2012 Apr; 78.

92. Dyck PJB, Tracy JA, Kiernan M, Dyck PJ, Crum BA, Mauermann ML, Amrami KK, Spinner RJ, Taylor BV. Unique nerve pathology distinguishes focal motor cidp from multifocal motor neuropathy. J Peripher Nerv Syst. 2013 Jun; 18:34.

93. Laughlin RS, Dyck PJB, Spinner RJ, Amrami KK, Watson JC, Staff NP. Postoperative ipsilateral inflammatory neuropathy after hip surgery. J Peripher Nerv Syst. 2013 Jun; 18:61.

Miscellaneous

1. Amrami KK. Basic Ultrasound. Meire H and Farrant P, editors (Book Review). Radiology. 1995; 197(1):182. (Book review)

2. Amrami KK. Manual of GI Fluoroscopy Javors B, editor (Book Review). Manual of GI Fluoroscopy Radiology. 1996; 201(2):320. (Book review)

3. Amrami KK. Atlas of Human Cross-Sectional Anatomy: With CT and MR Images. Cahill D, Orland M, Miller G, editors (Book Review). Radiology. 1996; 1999(1):208. (Book review)

Forthcoming

Ex. 12, page 4

Ex. 12, page 5

6/28/2016 Publications ­ Mayo Clinic

http://www.mayo.edu/research/searchpublications/publications?authid=11757761 1/16

Faculty

Kimberly K. Amrami, M.D.Publications1. Prasad NK , Mahan MA, Howe BM , Amrami KK , Spinner RJ . A new pattern oflipomatosis of nerve: case report. J Neurosurg 2016 May 6; 1­5 Epub 2016 May 06 View PubMed

2. Prasad NK , Desy NM , Howe BM , Amrami KK , Spinner RJ . Subparaneurialganglion cysts of the fibular and tibial nerves: A new variant of intraneural ganglioncysts. Clin Anat 2016 May; 29 (4):530­7 Epub 2015 Dec 18 View PubMed

3. Capek S , Krauss WE , Amrami KK , Parisi JE , Spinner RJ . Perineural Spread ofRenal Cell Carcinoma: A Case Illustration with a Proposed Anatomic Mechanismand a Review of the Literature. World Neurosurg 2016 May; 89:728.e11­7 Epub2016 Feb 02 View PubMed

4. Broski SM , Johnson GB , Howe BM , Nathan MA , Wenger DE , Spinner RJ ,Amrami KK . Evaluation of F­FDG PET and MRI in differentiating benign andmalignant peripheral nerve sheath tumors. Skeletal Radiol 2016 Apr 26 [Epubahead of print] View PubMed

5. Prasad NK , Amrami KK , Jentoft ME , Spinner RJ . Concurrent Lateral DorsalCutaneous and Deep Peroneal Intraneural Ganglion Cysts in the Foot. J Foot AnkleSurg 2016 Mar­Apr; 55 (2):401­5 Epub 2015 May 13 View PubMed

6. Capek S , Amrami KK , Howe BM , Collins MS , Sandroni P , Cheville JC , SpinnerRJ . Sequential imaging of intraneural sciatic nerve endometriosis provides insightinto symptoms of cyclical sciatica. Acta Neurochir (Wien) 2016 Mar; 158 (3):507­12Epub 2016 Jan 07 View PubMed

7. Prasad NK , Amrami KK , Jentoft ME , Spinner RJ . Concurrent lateral dorsalcutaneous and deep peroneal intraneural ganglion cysts in the foot Journal Of Foot& Ankle Surgery 2016 Mar­apr; 55 (2):401­5

8. Prasad NK, Chawla A, Lalezari S, de Ruiter GC, Howe BM, Amrami KK, SpinnerRJ. A radiological classification system for intraneural vascular anomalies:assessment of potential for resection with high­resolution MRI. Acta Neurochir(Wien) 2016 Feb; 158 (2):329­34 Epub 2015 Dec 23 View PubMed

9. Tiegs­Heiden CA , Murthy NS , Geske JR , Diehn FE , Schueler BA , Wald JT ,Kaufmann TJ , Lehman VT , Carr CM , Amrami KK , Morris JM , Thielen KR , MausTP . Fluoroscopically guided transforaminal epidural steroid injections at aquaternary­care teaching institution: effect of trainee involvement and patient body

mass index on fluoroscopy time and patient dose. Clin Radiol 2016 Jan; 71 (1):e16­

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mass index on fluoroscopy time and patient dose. Clin Radiol 2016 Jan; 71 (1):e16­20 Epub 2015 Nov 06 View PubMed

10. Desy NM, Lipinski LJ, Tanaka S, Amrami KK, Rock MG, Spinner RJ. Recurrentintraneural ganglion cysts: Pathoanatomic patterns and treatment implications. ClinAnat. 2015 Nov; 28(8):1058­69. Epub 2015 Sep 09. View PubMed

11. Siquara De Sousa AC, Capek S, Amrami KK, Spinner RJ. Neural involvement inendometriosis: Review of anatomic distribution and mechanisms. Clin Anat. 2015Nov; 28(8):1029­38. Epub 2015 Sep 09. View PubMed

12. Prasad NK , Capek S , de Ruiter GC, Amrami KK , Spinner RJ . Thesubparaneurial compartment: A new concept in the clinicoanatomic classification ofperipheral nerve lesions. Clin Anat 2015 Oct; 28 (7):925­30 Epub 2015 July 16 View PubMed

13. Lahoria R, Dyck PJ, Macon WR, Crum BA, Spinner RJ, Amrami KK, ZeldenrustSR, Tracy JA. Neurolymphomatosis: A report of 2 cases representing opposite endsof the clinical spectrum. Muscle Nerve. 2015 Sep; 52(3):449­54. Epub 2015 May 14.View PubMed

14. Capek S , Howe BM , Froemming AT , Amrami KK , Spinner RJ . Perineural spreadin pelvic malignancies can be an alternate explanation for pelvic bony metastasesrather than hematogenous spread. A report of two cases. Skeletal Radiol 2015 Sep;44 (9):1365­70 Epub 2015 Apr 12 View PubMed

15. Capek S , Howe BM , Amrami KK , Spinner RJ . Perineural spread of pelvicmalignancies to the lumbosacral plexus and beyond: clinical and imaging patterns.Neurosurg Focus 2015 Sep; 39 (3):E14 View PubMed

16. Siquara de Sousa AC, Capek S , Howe BM , Jentoft ME , Amrami KK , Spinner RJ. Magnetic resonance imaging evidence for perineural spread of endometriosis tothe lumbosacral plexus: report of 2 cases. Neurosurg Focus 2015 Sep; 39 (3):E15 View PubMed

17. Capek S , Amrami KK , Dyck PJ , Spinner RJ . Targeted fascicular biopsy of thesciatic nerve and its major branches: rationale and operative technique. NeurosurgFocus 2015 Sep; 39 (3):E12 View PubMed

18. Reddy CG, Amrami KK , Howe BM , Spinner RJ . Combined common peroneal andtibial nerve injury after knee dislocation: one injury or two? An MRI­clinicalcorrelation. Neurosurg Focus 2015 Sep; 39 (3):E8 View PubMed

19. Prasad NK , Spinner RJ , Smith J , Howe BM , Amrami KK , Iannotti JP, Dahm DL .The successful arthroscopic treatment of suprascapular intraneural ganglion cysts.Neurosurg Focus 2015 Sep; 39 (3):E11 View PubMed

20. Restrepo CE, Amrami KK , Howe BM , Dyck PJ , Mauermann ML , Spinner RJ .The almost­invisible perineurioma. Neurosurg Focus 2015 Sep; 39 (3):E13 View PubMed

21. Staff NP, Amrami KK, Howe BM. Magnetic resonance imaging abnormalities ofperipheral nerve and muscle are common in amyotrophic lateral sclerosis and sharefeatures with multifocal motor neuropathy. Muscle Nerve. 2015 Jul; 52(1):137­9.Epub 2015 May 28. View PubMed

22. Capek S , Hebert­Blouin MN , Puffer RC , Martinoli C , Frick MA , Amrami KK ,Spinner RJ . Tumefactive appearance of peripheral nerve involvement in

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Spinner RJ . Tumefactive appearance of peripheral nerve involvement inhematologic malignancies: a new imaging association. Skeletal Radiol 2015 Jul; 44(7):1001­9 Epub 2015 Apr 29 View PubMed

23. Capek S, Koutlas IG, Strasia RP, Amrami KK, Spinner RJ. An inferior alveolarintraneural cyst: a case example and an anatomical explanation to support thearticular theory within cranial nerves. J Neurosurg. 2015 Jun; 122(6):1433­7. Epub2015 Feb 06. View PubMed

24. Howe BM, Spinner RJ, Felmlee JP, Amrami KK. High­resolution imaging of upperlimb neuropathies. Semin Musculoskelet Radiol 2015 Apr; 19 (2):160­7 Epub 2015Mar 12 View PubMed

25. Shahgholi L, Yost KJ, Carter RE, Geske JR, Hagen CE, Amrami KK, Diehn FE,Kaufmann TJ, Morris JM, Murthy NS, Wald JT, Thielen KR, Kallmes DF, Maus TP.Correlation of the Patient Reported Outcomes Measurement Information Systemwith legacy outcomes measures in assessment of response to lumbartransforaminal epidural steroid injections. AJNR Am J Neuroradiol 2015 Mar; 36(3):594­9 Epub 2015 Jan 22 View PubMed

26. Capek S, Howe BM, Tracy JA, Garcia JJ, Amrami KK, Spinner RJ. Prostate cancerwith perineural spread and dural extension causing bilateral lumbosacralplexopathy: case report. J Neurosurg. 2015 Feb 06; 1­6. View PubMed

27. Shahid KR, Dellon AL, Amrami KK, Spinner RJ. Sciatic and peroneal nerve injuriesafter endovascular ablation of lower extremity varicosities: case reports and reviewof the literature. Ann Plast Surg. 2015 Jan; 74(1):64­8. View PubMed

28. Capek S, Sullivan PS, Howe BM, Smyrk TC, Amrami KK, Spinner RJ, Dozois EJ.Recurrent rectal cancer causing lumbosacral plexopathy with perineural spread tothe spinal nerves and the sciatic nerve: an anatomic explanation. Clin Anat. 2015Jan; 28(1):136­43. Epub 2014 Aug 05. View PubMed

29. Capek S, Amrami KK, Howe BM, Salomao DR, Dyck PJ, Spinner RJ. Perineuralspread of squamous cell carcinoma: from skin to skin through the brachial plexus.Clin Neurol Neurosurg. 2015 Jan; 128:90­3. Epub 2014 Nov 15. View PubMed

30. Crush AB, Howe BM, Spinner RJ, Amrami KK, Hunt CH, Johnson GB, Murphy RC,Morreale RF, Peller PJ. Malignant involvement of the peripheral nervous system inpatients with cancer: multimodality imaging and pathologic correlation.Radiographics. 2014 Nov­Dec; 34(7):1987­2007. View PubMed

31. Murthy NS, Geske JR, Shelerud RA, Wald JT, Diehn FE, Thielen KR, Kaufmann TJ,Morris JM, Lehman VT, Amrami KK, Carter RE, Maus TP. The effectiveness ofrepeat lumbar transforaminal epidural steroid injections. Pain Med. 2014 Oct;15(10):1686­94. Epub 2014 Jul 07. View PubMed

32. Mahan MA, Niederhauser BD , Amrami KK , Spinner RJ . Long­term progression oflipomatosis of nerve. World Neurosurg 2014 Sep­Oct; 82 (3­4):492­9 Epub 2013Sept 10 View PubMed

33. Spinner RJ, Harish S, Amrami KK. An historical perspective on ulnar intraneuralganglion cysts and their joint origins. Hand (N Y). 2014 Sep; 9(3):395­8. View PubMed

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34. Mahan MA, Howe BM, Amrami KK, Spinner RJ. Occult radiological effects oflipomatosis of the lumbosacral plexus. Skeletal Radiol. 2014 Jul; 43(7):963­8. Epub2014 Apr 12. View PubMed

35. El­Yahchouchi C, Wald J, Brault J, Geske J, Hagen C, Murthy N, Kaufmann T,Thielen K, Morris J, Diehn F, Amrami K, Carter R, Shelerud R, Maus T. Lumbartransforaminal epidural steroid injections: does immediate post­procedure painresponse predict longer term effectiveness? Pain Med. 2014 Jun; 15(6):921­8. Epub2014 Jan 21. View PubMed

36. Mahan MA, Amrami KK, Howe BM, Spinner RJ. Segmental thoracic lipomatosis ofnerve with nerve territory overgrowth. J Neurosurg. 2014 May; 120(5):1118­24.Epub 2014 Feb 07. View PubMed

37. Kumar R, Howe BM, Amrami KK, Spinner RJ. Neuromuscular choristoma of thesciatic nerve and lumbosacral plexus: an association with nerve­territoryundergrowth in the pelvis affecting soft tissue and bone. Acta Neurochir (Wien).2014 May; 156(5):1041­6. Epub 2014 Apr 01. View PubMed

38. Laughlin RS, Dyck PJ, Watson JC, Spinner RJ, Amrami KK, Sierra RJ, TrousdaleRT, Staff NP. Ipsilateral inflammatory neuropathy after hip surgery. Mayo Clin Proc.2014 Apr; 89(4):454­61. Epub 2014 Jan 04. View PubMed

39. Lehman VT, Murphy RC, Kaufmann TJ, Diehn FE, Murthy NS, Wald JT, Thielen KR,Amrami KK, Morris JM, Maus TP. Frequency of discordance between facet jointactivity on technetium Tc99m methylene diphosphonate SPECT/CT and selectionfor percutaneous treatment at a large multispecialty institution. AJNR Am JNeuroradiol. 2014 Mar; 35(3):609­14. Epub 2013 Sep 12. View PubMed

40. Howe BM, Amrami KK, Dyck PJ, Mauermann ML, Rooke TW, Spinner RJ. Hemi­body port­wine stains and progressive paresis due to territorial perineuriomas.Skeletal Radiol. 2014 Mar; 43(3):393­7. Epub 2013 Oct 04. View PubMed

41. Mahan MA, Ladak A, Johnston PB, Seningen JL, Amrami KK, Spinner RJ. Uniqueoccurrence of mucosa­associated lymphoid tissue lymphoma disseminated toperipheral nerves. J Surg Orthop Adv. 2013 Winter; 22(4):321­5. View PubMed

42. Alai A, Reddy CG, Amrami KK, Spinner RJ. Charcot arthropathy of the shoulderassociated with typical and atypical findings. Clin Anat. 2013 Nov; 26(8):1017­23.Epub 2012 Jun 13. View PubMed

43. Howe BM, Amrami KK, Nathan MA, Garcia JJ, Spinner RJ. Perineural spread ofcervical cancer to the sciatic nerve. Skeletal Radiol. 2013 Nov; 42(11):1627­31.Epub 2013 Jun 11. View PubMed

44. El­Yahchouchi C, Geske JR, Carter RE, Diehn FE, Wald JT, Murthy NS, KaufmannTJ, Thielen KR, Morris JM, Amrami KK, Maus TP. The noninferiority of thenonparticulate steroid dexamethasone vs the particulate steroids betamethasoneand triamcinolone in lumbar transforaminal epidural steroid injections. Pain Med.2013 Nov; 14(11):1650­7. Epub 2013 Jul 30 View PubMed

45. Babu MA, Spinner RJ, Dyck PJ, Amrami KK, Nathan MA, Kawashima A, Howe BM.Recurrent prostatic adenocarcinoma with perineural spread to the lumbosacralplexus and sciatic nerve: comparing high resolution MRI with torso and endorectal

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plexus and sciatic nerve: comparing high resolution MRI with torso and endorectalcoils and F­18 FDG and C­11 choline PET/CT. Abdom Imaging. 2013 Oct;38(5):1155­60. View PubMed

46. Mahan MA, Amrami KK, Spinner RJ. Sciatic nerve lipomatosis and kneeosteochondroma. J Neurosurg. 2013 Oct; 119(4):934. Epub 2013 Aug 09. View PubMed

47. Ringler MD, Howe BM, Amrami KK, Hagen CE, Berger RA. Utility of magneticresonance imaging for detection of longitudinal split tear of the ulnotriquetralligament. J Hand Surg Am. 2013 Sep; 38(9):1723­7. Epub 2013 Jul 30. View PubMed

48. Kaufmann TJ, Geske JR, Murthy NS, Thielen KR, Morris JM, Wald JT, Diehn FE,Amrami KK, Carter RE, Shelerud RA, Gay RE, Maus TP. Clinical effectiveness ofsingle lumbar transforaminal epidural steroid injections. Pain Med. 2013 Aug;14(8):1126­33. Epub 2013 Apr 22. View PubMed

49. Mahan MA, Amrami KK, Spinner RJ. Fibroproliferative neuromas may occur afteriatrogenic injury for lipomatosis of nerve. Neurosurgery. 2013 Aug; 73(2):271­81;discussion 281. View PubMed

50. Nagata S, Shen RK, Laack NN, Inwards CY, Wenger DE, Amrami KK.Chondrosarcoma arising within a radiation­induced osteochondroma several yearsfollowing childhood total body irradiation: case report. Skeletal Radiol. 2013 Aug;42(8):1173­7. Epub 2013 Apr 11. View PubMed

51. Diehn FE, Geske JR, Amrami KK, Kaufmann TJ, Morris JM, Murthy NS, ThielenKR, Wald JT, Shelerud RA, Carter RE, Maus TP. An audit of transforaminal epiduralsteroid injections without sedation: low patient dissatisfaction and low vasovagalrates. Pain Med. 2013 Jul; 14(7):994­8. Epub 2013 Apr 16. View PubMed

52. Mahan MA, Amrami KK, Niederhauser BD, Spinner RJ. Progressive nerve territoryovergrowth after subtotal resection of lipomatosis of the median nerve in the palmand wrist: a case, a review and a paradigm. Acta Neurochir (Wien). 2013 Jun;155(6):1131­41. Epub 2013 Apr 25. View PubMed

53. Niederhauser BD, Spinner RJ, Jentoft ME, Everist BM, Matsumoto JM, AmramiKK. Neuromuscular choristoma: characteristic magnetic resonance imaging findingsand association with post­biopsy fibromatosis. Skeletal Radiol. 2013 Apr; 42(4):567­77. Epub 2012 Nov 27. View PubMed

54. Ladak A, Spinner RJ, Amrami KK, Howe BM. MRI findings in patients with tibialnerve compression near the knee. Skeletal Radiol. 2013 Apr; 42(4):553­9. Epub2013 Jan 16. View PubMed

55. Puffer RC, Spinner RJ, Murthy NS, Amrami KK. CT and MR arthrogramsdemonstrate a consistent communication between the tibiofemoral and superiortibiofibular joints. Clin Anat. 2013 Mar; 26(2):253­7. Epub 2012 May 10. View PubMed

56. Ringler MD, Litwiller DV, Felmlee JP, Shahid KR, Finnoff JT, Carter RE, AmramiKK. MRI accurately detects chronic exertional compartment syndrome: a validationstudy. Skeletal Radiol. 2013 Mar; 42(3):385­92. Epub 2012 Jul 13. View PubMed

57. Spinner RJ, Desy NM, Agarwal G, Pawlina W, Kalra M, Amrami KK. Evidence tosupport that adventitial cysts, analogous to intraneural ganglion cysts, are also joint­

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support that adventitial cysts, analogous to intraneural ganglion cysts, are also joint­connected. Clin Anat. 2013 Mar; 26(2):267­81. Epub 2012 Aug 29 View PubMed

58. Reddy CG, Mauermann ML, Solomon BM, Ringler MD, Jerath NU, Begna KH,Amrami KK, Spinner RJ. Neuroleukemiosis: an unusual cause of peripheralneuropathy. Leuk Lymphoma. 2012 Dec; 53(12):2405­11. Epub 2012 May 28. View PubMed

59. Spinner RJ, Wang H, Howe BM, Colbert SH, Amrami KK. Deep ulnar intraneuralganglia in the palm. Acta Neurochir (Wien). 2012 Oct; 154(10):1755­63. Epub 2012Jun 23. View PubMed

60. Massie R, Mauermann ML, Staff NP, Amrami KK, Mandrekar JN, Dyck PJ, KleinCJ, Dyck PJ. Diabetic cervical radiculoplexus neuropathy: a distinct syndromeexpanding the spectrum of diabetic radiculoplexus neuropathies. Brain. 2012 Oct;135(Pt 10):3074­88. View PubMed

61. Tracy JA, Rubin DI, Amrami KK, Spinner RJ, Engelstad JK, Scheithauer BW, DyckPJ. Malignant peripheral nerve sheath tumor: the utility of fascicular biopsy andteased fiber studies. J Clin Neuromuscul Dis. 2012 Sep; 14(1):28­33. View PubMed

62. Spinner RJ, Ibrahim Elshiekh MA, Tubbs RS, Turner NS 3rd, Amrami KK.Posttraumatic torsional injury as an indirect cause of fibular intraneural ganglioncysts: case illustrations and potential mechanisms. Clin Anat. 2012 Jul; 25(5):641­6.Epub 2011 Oct 24. View PubMed

63. Amrami KK. Imaging of the seronegative spondyloarthopathies. Radiol Clin NorthAm. 2012 Jul; 50(4):841­54. View PubMed

64. Hayes ML, Larson AN, Skinner JA, Berger RA, Amrami KK. Quantification of radialtorsion angle with computerized tomography: a clinical study. J Surg Orthop Adv.2012 Summer; 21(2):92­5. View PubMed

65. Lalezari S, Amrami KK, Tubbs RS, Spinner RJ. Interosseous membrane: Theanatomic basis for combined ankle and common fibular (peroneal) nerve injuries.Clin Anat. 2012 Apr; 25(3):401­6. Epub 2011 Aug 30. View PubMed

66. Hebert­Blouin MN, Scheithauer BW, Amrami KK, Durham SR, Spinner RJ.Fibromatosis: a potential sequela of neuromuscular choristoma. J Neurosurg. 2012Feb; 116(2):399­408. Epub 2011 Aug 05. View PubMed

67. Spinner RJ, Scheithauer BW, Amrami KK, Wenger DE, Hebert­Blouin MN. Adiposelesions of nerve: the need for a modified classification. J Neurosurg. 2012 Feb;116(2):418­31. Epub 2011 Oct 07. View PubMed

68. Spinner RJ, Amrami KK, Ibrahim Elshiekh MA, Blitz NM. Sural Intraneural GanglionCysts Are Joint­related. Arch Plast Surg. 2012 Jan; 39(1):77­9. Epub 2012 Jan 15. View PubMed

69. Ehman EC, Hayes ML, Berger RA, Felmlee JP, Amrami KK. Subluxation of thedistal radioulnar joint as a predictor of foveal triangular fibrocartilage complex tears.J Hand Surg Am. 2011 Nov; 36(11):1780­4. View PubMed

70. Hebert­Blouin MN, Pirola E, Amrami KK, Wang H, Desy NM, Spinner RJ. Ananatomically based imaging sign to detect adventitial cyst derived from the superiortibiofibular joint. Clin Anat. 2011 Oct; 24(7):893­902. Epub 2011 Apr 21.

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tibiofibular joint. Clin Anat. 2011 Oct; 24(7):893­902. Epub 2011 Apr 21. View PubMed

71. Woodrum DA, Mynderse LA, Gorny KR, Amrami KK, McNichols RJ, Callstrom MR.3.0T MR­guided laser ablation of a prostate cancer recurrence in the postsurgicalprostate bed. J Vasc Interv Radiol. 2011 Jul; 22(7):929­34. View PubMed

72. Shahid KR, Hebert­Blouin MN, Amrami KK, Spinner RJ. Extraneural rupture ofintraneural ganglion cysts. J Surg Orthop Adv. 2011 Summer; 20(2):136­41. View PubMed

73. Gorny KR, Woodrum DA, Brown DL, Henrichsen TL, Weaver AL, Amrami KK,Hangiandreou NJ, Edmonson HA, Bouwsma EV, Stewart EA, Gostout BS, EhmanDA, Hesley GK. Magnetic resonance­guided focused ultrasound of uterineleiomyomas: review of a 12­month outcome of 130 clinical patients. J Vasc IntervRadiol. 2011 Jun; 22(6):857­64. Epub 2011 Apr 08. View PubMed

74. Shahid KR, Amrami KK, Esther RJ, Lowe VJ, Spinner RJ. False­negative fluorine­18 fluorodeoxyglucose positron emission tomography of a malignant peripheralnerve sheath tumor arising from a plexiform neurofibroma in the setting ofneurofibromatosis type 1. J Surg Orthop Adv. 2011 Summer; 20(2):132­5. View PubMed

75. Spinner RJ, Hebert­Blouin MN, Tanaka S, Amrami KK, Swartz KR, Fee DB, SugitaM. Letter to the Editor. J Neurosurg. 2011 Apr 29. [Epub ahead of print] View PubMed

76. Scheithauer BW, Amrami KK, Folpe AL, Silva AI, Edgar MA, Woodruff JM, Levi AD,Spinner RJ. Synovial sarcoma of nerve. Hum Pathol. 2011 Apr; 42(4):568­77. Epub2011 Feb 04. View PubMed

77. Garcia­Medina O, Gorny K, McNichols R, Friese J, Misra S, Amrami K, BjarnasonH, Callstrom M, Woodrum D. In vivo evaluation of a MR­guided 980nm laserinterstitial thermal therapy system for ablations in porcine liver. Lasers Surg Med.2011 Apr; 43(4):298­305. View PubMed

78. Spinner RJ, Puffer RC, Skinner JA, Amrami KK. The MRI appearance andimportance of the "very" terminal branches of the recurrent articular branch in fibularintraneural ganglion cysts. Clin Anat. 2011 Jan 03. [Epub ahead of print] View PubMed

79. Spinner RJ, Hebert­Blouin MN, Rock MG, Amrami KK. Extreme intraneuralganglion cysts. J Neurosurg. 2011 Jan; 114(1):217­24. Epub 2010 May 21. View PubMed

80. Amrami KK, Moran SL, Berger RA, Ehman EC, Felmlee JP. Imaging the distalradioulnar joint. Hand Clin. 2010 Nov; 26(4):467­75. View PubMed

81. Hebert­Blouin MN, Amrami KK, Spinner RJ. The normal and pathologic MRIappearance of the tibialis anterior proximal motor branch. Clin Anat. 2010 Nov;23(8):992­9. View PubMed

82. Staff NP, Engelstad J, Klein CJ, Amrami KK, Spinner RJ, Dyck PJ, Warner MA,Warner ME, Dyck PJ. Post­surgical inflammatory neuropathy. Brain. 2010 Oct;133(10):2866­80. Epub 2010 Sep 15. View PubMed

83. Van Gompel JJ, Griessenauer CJ, Scheithauer BW, Amrami KK, Spinner RJ.Vascular malformations, rare causes of sciatic neuropathy: a case series.Neurosurgery. 2010 Oct; 67(4):1133­42; discussion 1142. View PubMed

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84. Hebert­Blouin MN, Amrami KK, Myers RP, Hanna AS, Spinner RJ.Adenocarcinoma of the prostate involving the lumbosacral plexus: MRI evidence tosupport direct perineural spread. Acta Neurochir (Wien). 2010 Sep; 152(9):1567­76.Epub 2010 May 15. View PubMed

85. Spinner RJ, Hebert­Blouin MN, Amrami KK, Rock MG. Peroneal and tibialintraneural ganglion cysts in the knee region: a technical note. Neurosurgery. 2010Sep; 67(3 Suppl Operative):ons71­8; discussion ons78. View PubMed

86. Shahid KR, Spinner RJ, Skinner JA, Felmlee JP, Bond JR, Stanley DW, AmramiKK. Evaluation of intraneural ganglion cysts using three­dimensional fast spin echo­cube. J Magn Reson Imaging. 2010 Sep; 32(3):714­8. View PubMed

87. Mauermann ML, Scheithauer BW, Spinner RJ, Amrami KK, Nance CS, Kline DG,O'Connor MI, Dyck PJ, Engelstad J, Dyck PJ. Inflammatory pseudotumor of nerve:clinicopathological characteristics and a potential therapy. J Peripher Nerv Syst.2010 Sep; 15(3):216­26. View PubMed

88. Spinner RJ, Hebert­Blouin MN, Amrami KK. A complex cyst characterized into itsindividual components: a shared pathogenesis from the superior tibiofibular joint. JSurg Orthop Adv. 2010 Fall; 19(3):143­8. View PubMed

89. Tay SC, van Riet R, Kazunari T, Amrami KK, An KN, Berger RA. In­vivo kinematicanalysis of forearm rotation using helical axis analysis. Clin Biomech (Bristol, Avon).2010 Aug; 25(7):655­9. Epub 2010 May 18. View PubMed

90. Woodrum DA, Gorny KR, Mynderse LA, Amrami KK, Felmlee JP, Bjarnason H,Garcia­Medina OI, McNichols RJ, Atwell TD, Callstrom MR. Feasibility of 3.0Tmagnetic resonance imaging­guided laser ablation of a cadaveric prostate. Urology.2010 Jun; 75(6):1514.e1­6. Epub 2010 Apr 09. View PubMed

91. Mariappan YK, Manduca A, Glaser KJ, Chen J, Amrami KK, Ehman RL. Vibrationimaging for localization of functional compartments of the extrinsic flexor muscles ofthe hand. J Magn Reson Imaging. 2010 Jun; 31(6):1395­401. View PubMed

92. Shahid KR, Amrami KK, Spinner RJ. Primary monophasic synovial sarcomapresenting as a benign neurogenic tumor: case review and review of the literature. JSurg Orthop Adv. 2010 Summer; 19(2):129­33. View PubMed

93. Hebert­Blouin MN, Amrami KK, Wang H, Skinner JA, Spinner RJ. Tibialis anteriorbranch involvement in fibular intraneural ganglia. Muscle Nerve. 2010 Apr;41(4):524­32. View PubMed

94. Hebert­Blouin MN, Amrami KK, Scheithauer BW, Spinner RJ.Multinodular/plexiform (multifascicular) schwannomas of major peripheral nerves:an underrecognized part of the spectrum of schwannomas. J Neurosurg. 2010 Feb;112(2):372­82.

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95. Lachance DH, Lennon VA, Pittock SJ, Tracy JA, Krecke KN, Amrami KK, PoeschlaEM, Orenstein R, Scheithauer BW, Sejvar JJ, Holzbauer S, Devries AS, Dyck PJ.An outbreak of neurological autoimmunity with polyradiculoneuropathy in workersexposed to aerosolised porcine neural tissue: a descriptive study. Lancet Neurol.

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2010 Jan; 9(1):55­66. Epub 2009 Nov 27. View PubMed

96. Spinner RJ, Hebert­Blouin MN, Maus TP, Atkinson JL, Desy NM, Amrami KK.Evidence that atypical juxtafacet cysts are joint derived. J Neurosurg Spine. 2010Jan; 12(1):96­102. View PubMed

97. Koff MF, Stanley DW, Weishaar PJ, Amrami KK, Kaufman KR. Short­termrepeatability of joint space width measurements using a magnetic resonanceimaging compatible knee positioning device. Proc Inst Mech Eng H. 2010;224(9):1061­71. View PubMed

98. McPhail EF, Mynderse LA, Callstrom MR, Gorny KR, McNichols RJ, Atwell TD,Gettman MT, Amrami KK, Kawashima A, Woodrum DA. 1.5T MRI­guided trans­perineal laser ablation of locally recurrent prostate adenocarcinoma. Progress inBiomedical Optics and Imaging ­ Proceedings of SPIE. 2010; 7548:754816.

99. Spinner RJ, Scheithauer BW, Amrami KK. The unifying articular (synovial) origin ofintraneural ganglia: evolution­revelation­revolution. Neurosurgery. 2009 Oct; 65(4Suppl):A115­24. View PubMed

100. Pirola E, Hebert­Blouin MN, Amador N, Amrami KK, Spinner RJ. Palmarisprofundus: one name, several subtypes, and a shared potential for nervecompression. Clin Anat. 2009 Sep; 22(6):643­8. View PubMed

101. Mauermann ML, Amrami KK, Kuntz NL, Spinner RJ, Dyck PJ, Bosch EP, EngelstadJ, Felmlee JP, Dyck PJ. Longitudinal study of intraneural perineurioma­­a benign,focal hypertrophic neuropathy of youth. Brain. 2009 Aug; 132(Pt 8):2265­76. Epub2009 Jun 30. View PubMed

102. Spinner RJ, Hebert­Blouin MN, Trousdale RT, Midha R, Russell SM, Yamauchi T,Sasaki S, Amrami KK. Intraneural ganglia in the hip and pelvic region. Clinicalarticle. J Neurosurg. 2009 Aug; 111(2):317­25. View PubMed

103. Spinner RJ, Hebert­Blouin MN, Maniker AH, Amrami KK. Clock face model appliedto tibial intraneural ganglia in the popliteal fossa. Skeletal Radiol. 2009 Jul;38(7):691­6. Epub 2009 Feb 17. View PubMed

104. Anakwenze OA, Parker WL, Wold LE, Amrami KK, Amadio PC. Ewing's sarcomaof the hand. J Hand Surg Eur Vol. 2009 Feb; 34(1):35­9. Epub 2008 Dec 17. View PubMed

105. Wang H, Terrill RQ, Tanaka S, Amrami KK, Spinner RJ. Adherence of intraneuralganglia of the upper extremity to the principles of the unifying articular (synovial)theory. Neurosurg Focus. 2009 Feb; 26(2):E10. View PubMed

106. Koff MF, Parratte S, Amrami KK, Kaufman KR. Examiner repeatability of patellarcartilage T2 values. Magn Reson Imaging. 2009 Jan; 27(1):131­6. Epub 2008 Sep17. View PubMed

107. Spinner RJ, Wang H, Hebert­Blouin MN, Skinner JA, Amrami KK. Sciatic cross­over in patients with peroneal and tibial intraneural ganglia confirmed by knee MRarthrography. Acta Neurochir (Wien) 2009 Jan; 151(1):89­98. Epub 2009 Jan 16. View PubMed

108. Blitz NM, Amrami KK, Spinner RJ. Magnetic resonance imaging of a deep peronealintraneural ganglion cyst originating from the second metatarsophalangeal joint: a

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intraneural ganglion cyst originating from the second metatarsophalangeal joint: apattern of propagation supporting the unified articular (synovial) theory for theformation of intraneural ganglia. J Foot Ankle Surg. 2009 Jan­Feb; 48(1):80­4. View PubMed

109. Spinner RJ, Luthra G, Desy NM, Anderson ML, Amrami KK. The clock face guideto peroneal intraneural ganglia: critical "times" and sites for accurate diagnosis.Skeletal Radiol. 2008 Dec; 37(12):1091­9. Epub 2008 Jul 19. View PubMed

110. Koff MF, Amrami KK, Felmlee JP, Kaufman KR. Bias of cartilage T2 values relatedto method of calculation. Magn Reson Imaging. 2008 Nov; 26(9):1236­43. Epub2008 May 07. View PubMed

111. Amrami KK, Felmlee JP, Spinner RJ. MRI of peripheral nerves. Neurosurg Clin NAm. 2008 Oct; 19(4):559­72, vi. View PubMed

112. Spinner RJ, Amrami KK. What's new in the management of benign peripheralnerve lesions? Neurosurg Clin N Am. 2008 Oct; 19(4):517­31, v. View PubMed

113. Amrami KK, Felmlee JP. 3­Tesla imaging of the wrist and hand: techniques andapplications. Semin Musculoskelet Radiol. 2008 Sep; 12(3):223­37. View PubMed

114. Khan FA, Koff MF, Noiseux NO, Bernhardt KA, O'Byrne MM, Larson DR , AmramiKK , Kaufman KR . Effect of local alignment on compartmental patterns of kneeosteoarthritis. J Bone Joint Surg Am 2008 Sep; 90 (9):1961­9 View PubMed

115. Anderson ML, Skinner JA, Felmlee JP, Berger RA, Amrami KK. Diagnosticcomparison of 1.5 Tesla and 3.0 Tesla preoperative MRI of the wrist in patients withulnar­sided wrist pain. J Hand Surg Am. 2008 Sep; 33(7):1153­9. View PubMed

116. Agnesi F, Amrami KK, Frigo CA, Kaufman KR. Comparison of cartilage thicknesswith radiologic grade of knee osteoarthritis. Skeletal Radiol. 2008 Jul; 37(7):639­43.Epub 2008 May 07. View PubMed

117. Blitz NM, Prestridge J, Amrami KK, Spinner RJ. A posttraumatic, joint­connectedsural intraneural ganglion cyst­with a new mechanism of intraneural recurrence: acase report. J Foot Ankle Surg. 2008 May­Jun; 47(3):199­205. Epub 2008 Mar 10. View PubMed

118. Anderson ML, Larson AN, Moran SL, Cooney WP, Amrami KK, Berger RA. Clinicalcomparison of arthroscopic versus open repair of triangular fibrocartilage complextears. J Hand Surg Am. 2008 May­Jun; 33(5):675­82. View PubMed

119. Spinner RJ, Carmichael SW, Wang H, Parisi TJ, Skinner JA, Amrami KK. Patternsof intraneural ganglion cyst descent. Clin Anat. 2008 Apr; 21(3):233­45. View PubMed

120. Spinner RJ, Amrami KK, Wang H, Kliot M, Carmichael SW. Cross­over: ageneralizable phenomenon necessary for secondary intraneural ganglion cystformation. Clin Anat. 2008 Mar; 21(2):111­8. View PubMed

121. Scheithauer BW, Rodriguez FJ, Spinner RJ, Dyck PJ, Salem A, Edelman FL,Amrami KK, Fu YS. Glomus tumor and glomangioma of the nerve. Report of twocases. J Neurosurg. 2008 Feb; 108(2):348­56. View PubMed

122. Lopez O, Amrami KK, Manduca A, Ehman RL. Characterization of the dynamic

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122. Lopez O, Amrami KK, Manduca A, Ehman RL. Characterization of the dynamicshear properties of hyaline cartilage using high­frequency dynamic MRelastography. Magn Reson Med. 2008 Feb; 59(2):356­64. View PubMed

123. Spinner RJ, Desy NM, Amrami KK. Sequential tibial and peroneal intraneuralganglia arising from the superior tibiofibular joint. Skeletal Radiol. 2008 Jan;37(1):79­84. Epub 2007 Oct 30. View PubMed

124. Tay SC, van Riet R, Kazunari T, Koff MF, Amrami KK, An KN, Berger RA. A methodfor in­vivo kinematic analysis of the forearm. J Biomech. 2008; 41(1):56­62. Epub2007 Sep 12. View PubMed

125. Tay SC, Primak AN, Fletcher JG, Schmidt B, Amrami KK, Berger RA, McColloughCH. Four­dimensional computed tomographic imaging in the wrist: proof offeasibility in a cadaveric model. Skeletal Radiol. 2007 Dec; 36(12):1163­9. Epub2007 Sep 06. View PubMed

126. Angius D, Shaughnessy WJ, Amrami KK, Matsumoto JM, Spinner RJ.Infraclavicular brachial plexopathy secondary to coracoid osteoid osteoma. J SurgOrthop Adv. 2007 Winter; 16(4):199­203. View PubMed

127. Litwiller DV, Amrami KK, Dahm DL, Smith J, Laskowski ER, Stuart MJ, Felmlee JP.Chronic exertional compartment syndrome of the lower extremities: improvedscreening using a novel dual birdcage coil and in­scanner exercise protocol.Skeletal Radiol. 2007 Nov; 36(11):1067­75. Epub 2007 Aug 15. View PubMed

128. Spinner RJ, Wang H, Carmichael SW, Amrami KK, Scheithauer BW. Epineurialcompartments and their role in intraneural ganglion cyst propagation: anexperimental study. Clin Anat. 2007 Oct; 20(7):826­33. Epub 2007 Jun 08. View PubMed

129. Amrami KK, Desy NM, Stanley DW, Skinner JA, Felmlee JP, Barger AV, Block WF,Spinner RJ. Evaluation of ganglion cysts using vastly undersampled isotropicprojection reconstruction (VIPR). J Magn Reson Imaging. 2007 Sep; 26(3):768­72.Epub 2007 Aug 8. View PubMed

130. Spinner RJ, Scheithauer BW, Perry A, Amrami KK, Emnett R, Gutmann DH.Colocalized cellular schwannoma and plexiform neurofibroma in the absence ofneurofibromatosis. Case report. J Neurosurg. 2007 Aug; 107(2):435­9. View PubMed

131. Spinner RJ, Amrami KK, Wolanskyj AP, Desy NM, Wang H, Benarroch EE, SkinnerJA, Rock MG, Scheithauer BW. Dynamic phases of peroneal and tibial intraneuralganglia formation: a new dimension added to the unifying articular theory. JNeurosurg. 2007 Aug; 107(2):296­307. View PubMed

132. Agnesi F, Amrami KK, Frigo CA, Kaufman KR. Semiautomated digital analysis ofknee joint space width using MR images. Skeletal Radiol. 2007 May; 36(5):437­44.Epub 2007 Jan 23.

View PubMed

133. Reach JS Jr, Amrami KK, Felmlee JP, Stanley DW, Alcorn JM, Turner NS. Thecompartments of the foot: a 3­tesla magnetic resonance imaging study with clinicalcorrelates for needle pressure testing. Foot Ankle Int. 2007 May; 28(5):584­94. View PubMed

134. Spinner RJ, Scheithauer BW, Amrami KK. Medial plantar nerve compression by atibial artery schwannoma. Case report. J Neurosurg. 2007 May; 106(5):921­3.

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tibial artery schwannoma. Case report. J Neurosurg. 2007 May; 106(5):921­3. View PubMed

135. Spinner RJ, Mokhtarzadeh A, Schiefer TK, Krishnan KG, Kliot M, Amrami KK. Theclinico­anatomic explanation for tibial intraneural ganglion cysts arising from thesuperior tibiofibular joint. Skeletal Radiol. 2007 Apr; 36(4):281­92. View PubMed

136. Tay SC, Berger RA, Tomita K, Tan ET, Amrami KK, An KN. In vivo three­dimensional displacement of the distal radioulnar joint during resisted forearmrotation. J Hand Surg Am. 2007 Apr; 32(4):450­8. View PubMed

137. Reach JS, Amrami KK, Felmlee JP, Stanley DW, Alcorn JM, Turner NS,Carmichael SW. Anatomic compartments of the foot: A 3­Tesla magnetic resonanceimaging study. Clin Anat. 2007 Mar; 20(2):201­8. View PubMed

138. Koff MF, Amrami KK, Kaufman KR. Clinical evaluation of T2 values of patellarcartilage in patients with osteoarthritis. Osteoarthritis Cartilage. 2007 Feb;15(2):198­204. Epub 2006 Sep 01. View PubMed

139. Lopez O, Amrami KK, Manduca A, Rossman PJ, Ehman RL. Developments indynamic MR elastography for in vitro biomechanical assessment of hyaline cartilageunder high­frequency cyclical shear. J Magn Reson Imaging. 2007 Feb; 25(2):310­20. View PubMed

140. Wang H, Spinner RJ, Amrami KK. Adventitial cyst of the radial artery with a wristjoint connection. J Hand Surg Am. 2007 Jan; 32(1):126­30. View PubMed

141. Spinner RJ, Dellon AL, Rosson GD, Anderson SR, Amrami KK. Tibial intraneuralganglia in the tarsal tunnel: Is there a joint connection? J Foot Ankle Surg. 2007Jan­Feb; 46(1):27­31. View PubMed

142. Spinner RJ, Desy NM, Rock MG, Amrami KK. Peroneal intraneural ganglia. Part II.Lessons learned and pitfalls to avoid for successful diagnosis and treatment.Neurosurg Focus. 2007; 22(6):E27. Epub 2007 Jun 15. View PubMed

143. Williams Z, Amrami KK, Spinner RJ. Tumoral calcinosis producing peripheral nervecompression: a report of two cases. Neurosurg Focus. 2007; 22(6):E20 Epub 2007Jun 15. View PubMed

144. Spinner RJ, Amrami KK, Angius D, Wang H, Carmichael SW. Peroneal and tibialintraneural ganglia: correlation between intraepineurial compartments observed onmagnetic resonance images and the potential importance of these compartments.Neurosurg Focus. 2007; 22(6):E17. Epub 2007 Jun 15. View PubMed

145. Spinner RJ, Desy NM, Rock MG, Amrami KK. Peroneal intraneural ganglia. Part I.Techniques for successful diagnosis and treatment. Neurosurg Focus. 2007;22(6):E16. Epub 2007 Jun 15. View PubMed

146. Spinner RJ, Mokhtarzadeh A, Schiefer TK, Krishnan KG, Kliot M, Amrami KK. Theclinico­anatomic explanation for tibial intraneural ganglion cysts arising from thesuperior tibiofibular joint. Skeletal Radiology. 2006 Dec 23:e­pub.

147. Ladha SS, Dyck PJ, Spinner RJ, Perez DG, Zeldenrust SR, Amrami KK, SolomonA, Klein CJ. Isolated amyloidosis presenting with lumbosacral radiculoplexopathy:description of two cases and pathogenic review. J Peripher Nerv Syst. 2006 Dec;

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11(4):346­52. View PubMed

148. Spinner RJ, Endo T, Amrami KK, Dozois EJ, Babovic­Vuksanovic D, Sim FH.Resection of benign sciatic notch dumbbell­shaped tumors. J Neurosurg. 2006 Dec;105(6):873­80. View PubMed

149. Ladha SS, Spinner RJ, Suarez GA, Amrami KK, Dyck PJ. Neoplastic lumbosacralradiculoplexopathy in prostate cancer by direct perineural spread: an unusual entity.Muscle Nerve. 2006 Nov; 34(5):659­65. View PubMed

150. de Ruiter GC, Scheithauer BW, Amrami KK, Spinner RJ. Benign metastasizingleiomyomatosis with massive brachial plexus involvement mimickingneurofibromatosis type 1. Clin Neuropathol. 2006 Nov­Dec; 25(6):282­7. View PubMed

151. Spinner RJ, Scheithauer BW, Desy NM, Rock MG, Holdt FC, Amrami KK.Coexisting secondary intraneural and vascular adventitial ganglion cysts of jointorigin: a causal rather than a coincidental relationship supporting an articular theory.Skeletal Radiol. 2006 Oct; 35(10):734­44. Epub 2006 Jun 24. View PubMed

152. Reach JS Jr, Amrami KK, Felmlee JP, Stanley DW, Alcorn JM, Turner NS,Carmichael SW. Anatomic compartments of the foot: A 3­Tesla magnetic resonanceimaging study. Clin Anat. 2006 Aug 30; e­pub ahead of print.

153. Spinner RJ, Desy NM, Amrami KK. Cystic transverse limb of the articular branch: apathognomonic sign for peroneal intraneural Ganglia at the superior tibiofibular joint.Neurosurgery. 2006 Jul; 59(1):157­66; discussion 157­66. View PubMed

154. Parker WL, Beckenbaugh RR, Amrami KK. Calcifying aponeurotic fibroma of thehand: radiologic differentiation from giant cell tumors of the tendon sheath. J HandSurg Am. 2006 Jul­Aug; 31(6):1024­8. View PubMed

155. Spinner RJ, Edwards PK, Amrami KK. Application of three­dimensional renderingin joint­related ganglion cysts. Clin Anat. 2006 May; 19(4):312­22. View PubMed

156. Morton MJ, Whaley DH, Brandt KR, Amrami KK. Screening mammograms:interpretation with computer­aided detection­­prospective evaluation. Radiology.2006 May; 239(2):375­83. Epub 2006 Mar 28. View PubMed

157. Amrami KK. Magnetic resonance arthrography of the wrist: case presentation anddiscussion. J Hand Surg Am. 2006 Apr; 31(4):669­72. View PubMed

158. Spinner RJ, Amrami KK, Kliot M, Johnston SP, Casanas J. Suprascapularintraneural ganglia and glenohumeral joint connections. J Neurosurg. 2006 Apr;104(4):551­7. View PubMed

159. Spinner RJ, Amrami KK, Rock MG. The use of MR arthrography to document anoccult joint communication in a recurrent peroneal intraneural ganglion. SkeletalRadiol. 2006 Mar; 35(3):172­9. Epub 2005 Dec 07. View PubMed

160. Wong BZ, Amrami KK, Wenger DE, Dyck PJ, Scheithauer BW, Spinner RJ.Lipomatosis of the sciatic nerve: typical and atypical MRI features. Skeletal Radiol.2006 Mar; 35(3):180­4. Epub 2005 Nov 08. View PubMed

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161. White JB, Scheithauer BW, Amrami KK, Babovic­Vuksanovic D, Spinner RJ.Contiguous conventional and plexiform schwannomas. Report of two cases. JNeurosurg. 2006 Feb; 104(2):319­24. View PubMed

162. Amrami KK, Berger RA. Radiology corner: osteoid osteoma of the index finger:case presentation and discussion. J Hand Surg Am. 2006 Feb; 31(2):322­4. View PubMed

163. Desy NM, Amrami KK, Spinner RJ. Ganglion cysts and nerves. NeurosurgeryQuarterly. 2006; 16(4):187­94. View PubMed

164. Grochowski SK, Amrami KK, Kaufman K. Semi­automated digital image analysis ofpatellofemoral joint space width from lateral knee radiographs. Skeletal Radiol. 2005Oct; 34(10):644­8. View PubMed

165. Schmidt JE, Amrami KK, Manduca A, Kaufman KR. Semi­automated digital imageanalysis of joint space width in knee radiographs. Skeletal Radiol. 2005 Oct;34(10):639­43. View PubMed

166. Meisamy S, Bolan PJ, Baker EH, Pollema MG, Le CT, Kelcz F, Lechner MC,Luikens BA, Carlson RA, Brandt KR, Amrami KK, Nelson MT, Everson LI, EmoryTH, Tuttle TM, Yee D, Garwood M. Adding in vivo quantitative H­1 MR spectroscopyto improve diagnostic accuracy of breast MR imaging: Preliminary results ofobserver performance study at 4.0 T. Radiology. 2005 Aug; 236(2):465­75. View PubMed

167. Amrami KK, Berger RA. Radiology corner: Review of plain radiographs. Journal ofthe American Society for Surgery of the Hand. 2005; 5(1):4­7. View PubMed

168. Amrami KK, Port JD. Imaging the brachial plexus. Hand Clin. 2005 Feb; 21(1):25­37. View PubMed

169. Wong BZY, Amrami KK, Wenger DE, Dyck PJB, Scheithauer BW, Spinner RJ.Lipomatosis of the sciatic nerve: typical and atypical MRI features. Skeletal Radiol.2005 Nov 8;:1­5. Epub ahead of print.

170. Spinner RJ, Amrami KK, Dyck PJ, Dyck PJB, Klein CJ, Low PA, Sandroni P,Suarez GA, Windebank AJ. Fascicular Nerve Biopsies Produce Diagnoses forPatients Who Previously Had None. Neurosciences Update. 2005; 2(2):1­2. View PubMed

171. de Ruiter GC, Torchia ME, Amrami KK, Spinner RJ. Neurovascular compressionfollowing isolated popliteus muscle rupture: a case report. J Surg Orthop Advances.2005; 14(3):129­32. View PubMed

172. Amrami KK. Radiology corner: Basic principles of MRI for hand surgeons. Journalof the American Society for Surgery of the Hand. 2005; 5(2):81­6. View PubMed

173. Amrami KK. Radiology corner: Diagnosing radiographically occult scaphoidfractures ­ What's the best second test? Journal of the American Society for Surgeryof the Hand. 2005; 5(3):134­8. View PubMed

174. Amrami KK, Bishop AT, Berger RA. Radiology corner: Imaging soft­tissue tumors ofthe hand and wrist: Case presentation and discussion. Journal of the AmericanSociety for Surgery of the Hand. 2005; 5(4):186­92. View PubMed

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175. Davila JA, Amrami KK, Sundaram M, Adkins MC, Unni KK. Chondroblastoma ofthe hands and feet. Skeletal Radiol. 2004 Oct; 33(10):582­7. View PubMed

176. Lanners DM, Amrami KK, Jonsgaard RS, Gisvold JJ, Felmlee JP. Safety and MRIartifact evaluation at 1.5T of metallic mounting sheath of a marking clip inadvertentlydeployed at stereotactic biopsy. Am J Roentgenol. 2004 Sep; 183(3):825­9. View PubMed

177. Amrami KK, Ruggieri AP, Sundaram M. Radiologic case study ­ Rheumatoidarthritis with rice bodies. Orthopedics. 2004 Apr; 27(4):350, 426­427. View PubMed

178. Lopez O, Amrami KK, Rossman P, Ehman RL. Using magnetic resonanceelastography to assess the dynamic mechanical properties of cartilage. MedicalImaging. 2004: Physiology, Function, and Structure from Medical Images (SPIE)2004 Feb; 4(23):51­61. View PubMed

179. Amrami KK, Sundaram M, Shin AY, Bishop AT. Mycobacterium marinum infectionsof the distal upper extremities: clinical course and imaging findings in two cases withdelayed diagnosis. Skeletal Radiol. 2003 Sep; 32(9):546­9. Epub 2003 May 28. View PubMed

180. Jones TP, Beckenbaugh JP, Sperling JW, Amrami KK, Sundaram M. Radiologiccase study ­ Posterior shoulder dislocation. Orthopedics. 2003 Jul; 26(7):682, 745­6. View PubMed

181. Itoi E, Lee SB, Amrami KK, Wenger DE, An KN. Quantitative assessment of classicanteroinferior bony Bankart lesions by radiography and computed tomography. AmJ Sports Med. 2003 Jan­Feb; 31(1):112­8. View PubMed

182. Amrami KK, Sundaram M. Radiologic case study. Orthopedics. 2002 Dec;25(12):1344, 1431­1432. View PubMed

183. Amrami KK, Askari KS, Pagnano MW, Sundaram M. Radiologic Case Study ­Abrasion chondroplasty mimicking avascular necrosis. Orthopedics. 2002 Oct;25(10):1018, 1107­8. View PubMed

184. Amrami KK, Savcenko V, Dahm DL, Sundaram M. Radiologic Case Study. ReverseBankart lesion with posterior labral tear. Orthopedics. 2002 Jul; 25(7):720, 779­80. View PubMed

185. Kocharian A, Adkins MC, Amrami KK, McGee KP, Rouleau PA, Wenger DE,Ehman RL, Felmlee JP. Wrist: improved MR imaging with optimized transmit­receive coil design. Radiology. 2002 Jun; 223(3):870­6. View PubMed

186. Lauder TD, Stuart MJ, Amrami KK, Felmlee JP. Exertional compartment syndromeand the role of magnetic resonance imaging. American Journal of Physical Medicine

& Rehabilitation. 2002 Apr; 81(4):315­9. View PubMed

187. Amrami KK, Sperling JW, Bartholmai BJ, Sundaram M. Radiologic case study ­Glenolabral articular disruption (GLAD) lesion. Orthopedics. 2002 Jan; 25(1):29, 95­6. View PubMed

188. Boon AJ, Smith J, Zobitz ME, Amrami KM. Snowboarder's talus fracture.Mechanism of injury. Am J Sports Med. 2001 May­Jun; 29(3):333­8. View PubMed

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189. Baraga JJ, Amrami KK, Swee RG, Wold L, Unni KK. Radiographic features ofEwing's sarcoma of the bones of the hands and feet. Skeletal Radiol. 2001 Mar;30(3):121­6. View PubMed

190. du Cret RP, Haidet GC, Amrami KM, Boudreau RJ, Kuni CC. Factors affecting dataacquisition during gated radionuclide ventriculography. Semin Nucl Med. 1994 Jan;24(1):81­3. View PubMed

191. Latchaw RE, Remley KB, Amrami KK. Diagnostic imaging of the brain stem.Neurosurg Clin N Am. 1993 Jul; 4(3):433­56. View PubMed

192. Garfinkel BD, Amrami KK. A perspective on the attention­deficit disorders. Hospital& Community Psychiatry. 1992 May; 43(5):445­6, 448. View PubMed

193. Garfinkel BD, Amrami KK. Assessment and differential diagnosis of attentiondeficit­hyperactivity disorder. Child Adolesc Psychiatr Clin N Am. 1992; 1(2):311­423.

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Ex. 12, page 21

January 1, 2016 CURRICULUM VITAE

G. Caleb Alexander, MD, MS

PERSONAL DATA

Business Address

Johns Hopkins School of Public Health Center for Drug Safety and Effectiveness Department of Epidemiology 615 N. Wolfe Street W6035 Baltimore, MD 21205 Phone: 410 955 8168 Fax: 410 955 0863 Email: galexand@jhsph.edu

Clinical Address

Johns Hopkins at Green Spring Station 10753 Falls Road Suite 325 Lutherville, MD 21093 Clinic Phone: 410 583 2926 Clinic Fax: 410 583 2883

EDUCATION AND TRAINING

1988-1990 Candidate for BA, Oberlin College 1991-1993 University of Pennsylvania, BA (Philosophy) 1994-1998 Case Western Reserve University, MD 1998-1999 Intern, Internal Medicine, University of Pennsylvania 1999-2001 Resident, Internal Medicine, University of Pennsylvania 2001-2003 Robert Wood Johnson Clinical Scholar, University of Chicago 2002-2003 University of Chicago, Department of Health Studies, MS

Medical Licensure

Illinois Physician and Controlled Substance License, through 2014Drug Enforcement Agency Controlled Substance Licensure, through 2014Maryland Physician and Controlled Substance License, through 2014

Medical Board Certification

American Board of Internal Medicine, through 2021

PROFESSIONAL EXPERIENCE

2014- Affiliate Faculty, Center for Health Services and Outcomes Research (CHSOR), Johns Hopkins University

2012- Associate Professor of Epidemiology and Medicine, Johns Hopkins Bloomberg School of Public Health

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Ex. 12, page 22

HONORS AND AWARDS Honors

1993 Cum Laude, University of Pennsylvania 1997 Alpha Omega Alpha, Case Western Reserve University

John A. Oremus Memorial Scholar ($ (b) (4)2003-2005 Research Stipend), MacLean Center for Medical Ethics, University of Chicago

2006 Top 5% of reviewers, Medical Care (also received annually through 2011) 2007 Top 10% of reviewers, Ann Intern Med (also received 2008, 2009, 2014) 2011 Elected Fellow of the American College of Physicians (FACP) 2011 Top Reviewers, Pharmacoepidemiology and Drug Safety (annually through 2014)

Awards 2001 Edward W. Holmes Resident Research Award, University of Pennsylvania 2006-2009 Robert Wood Johnson Foundation Faculty Scholar Career Development Award 2007 Research Finalist, International Society for Pharmacoeconomics and Outcomes

Research, Annual Meeting 2008 Outstanding Physician Scientist Award, Central Society for Clinical Research

Career development award ($ (b) (4)2008 Research Stipend), Central Society for Clinical Research

2008 Department of Medicine Research Award (awarded to trainee for mentored research; also received by mentored trainees in 2009 and 2010)

2009 Pritzker School of Medicine Sigma Xi Award for Impact on Science (awarded to trainee for mentored research)

PUBLICATIONS

Peer Reviewed Journal Articles (b) (6)

1. Szele F, Alexander GC, Chesselet MF. "Expression of molecules associated with neuronal plasticity in the striatum after aspiration versus thermocoagulatory lesions in the adult cortex in adult rats." Journal of Neuroscience. 1995;15:4429-4448. PMID: 7790918

2. Alexander GC, Fera B, Ellis R. "From the students: learning continuous improvement by doing it." Joint Commission Journal on Quality Improvement. 1996;22:198-205. PMID: 8664952

3. Alexander GC, Sehgal AR. Dialysis patient assessments of the quality of medical care provided by generalists, nephrologists and other specialists. American Journal of Kidney Disease. 1998;32:284-289. PMID: 9708614

4. Alexander GC, Sehgal AR. Barriers to cadaveric renal transplantation among blacks, women, and the poor. JAMA. 1998;280:1148-1152. PMID: 9777814

Editorial: Milford EL. Organ transplantation--barriers, outcomes, and evolving policies. JAMA. 1998;280:1184-1185. PMID: 9777820

5. Lewin L, Agneberg B, Alexander GC. A course in end-of-life care for third year medical students. Academic Medicine. 2000:57:519-520. PMID: 10824792

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121.Kornfield R, Alexander GC, Qato DM, Kim Y, Hirsch JD, Emery SL. Trends in Exposure to Televised Prescription Drug Advertising, 2003-2011. American Journal of Preventive Medicine. 2015;48:575-579.

(b) (4)

123.Daubresse M, Alexander GC. The Uphill Battle Facing Antiobesity Drugs. International Journal of Obesity. 2015;39:377-378.

124.Hampton LM, Daubresse M, Chang HY, Alexander GC, Budnitz DS. Emergency Department Visits by Children and Adolescents for Antipsychotic Drug Adverse Events. JAMA Psychiatry. 2015;72:292-294.

125.Viswanathan S, Justice AC, Alexander GC, Brown TT, Gandi NR, McNicholl IR, Rimland D, Rodriguez-Barradas MC, Jacobson LP. Adherence and HIV RNA Suppression in the Current Era of Highly Active Antiretroviral Therapy (HAART). Journal of Acquired Immune Deficiency Syndromes. 2015;69:493-498.

126.Riggs KR, Buttorff C, Alexander GC. Impact of Out-of-pocket Spending Caps on Financial Burden of Those with Group Health Insurance. Journal of General Internal Medicine. 2015;30:683-8.

127.Rutkow L, Turner L, Lucas E, Hwang C, Alexander GC. Most Primary Care Physicians are Aware of Prescription Drug Monitoring Programs, But Many Find the Data Difficult to Access. Health Affairs. 2015;34:484-492.

128.Chang HY, Zhou M, Tang W, Alexander GC, Singh S. Risk of Gastrointestinal Bleeding Associated With Oral Anticoagulants: Population Based Retrospective Cohort Study. British Medical Journal. 2015;350:h1585.

Editorial: Sarrazin MSV, Rose A. Safety of New Oral Anticoagulants. British Medical Journal. 2015;350:h1679.

129.Abraham NS, Singh S, Alexander GC, Heien H, Haas LR, Crown W, Shah ND. Comparative Risk of Gastrointestinal Bleeding with Dabigatran, Rivaroxaban and Warfarin: Population Based Cohort Study. British Medical Journal. 2015;350:h1857.

Editorial: Sarrazin MSV, Rose A. Safety of New Oral Anticoagulants. British Medical Journal. 2015;350:h1679.

130.Buttorff C, Andersen MS, Riggs KR, Alexander GC. Comparing Employer-Sponsored and Federal Exchange Plans: Wide Variations in Cost Sharing for Prescription Drugs. Health Affairs. 2015;34:467-476.

131.Dusetzina SB, Ellis S, Freedman RA, Conti RM, Winn AN, Chambers JD, Alexander GC, Huskamp HA, Keating NL. How Do Payers Respond to Regulatory Actions? The Case of Bevacizumab. Journal of Oncology Practice. 2015;11:313-318.

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Ex. 12, page 26

(b) (4)

17

Ex. 12, page 27

(b) (4)

Articles and Editorials not peer reviewed (b) (6)

1. Alexander GC. "On Remaining Human." Becoming Doctors. Student Doctors Press, La Grange Park, IL: pp 226-228, 1995 (essay).

2. Alexander GC, Weiss A, George S. "Virtual Medical School." The New Physician. Oct 1996: 16-17 (manuscript).

3. Alexander GC. Course Guide – Caring for Patients Near the End-of-Life. Case Western Reserve University - School of Medicine, 1997;1-88 (curriculum).

4. Alexander GC, Weiss A. Providing laptops to promote computer use: lessons learned. Academic Medicine. 1998;73:224-225 (letter).

5. Alexander GC. Patient care and student education. Virtual Mentor: Ethics Journal of the American Medical Association. Available at: http://www.ama-assn.org/ama/pub/category/7678.html Accessed April 26, 2002 (invited commentary).

6. Alexander GC, Kwiatkowski C. Diagnosing and managing adverse drug events in hospitalized patients. Topics in Drug Therapy (University of Chicago). 2003;45:1-8. (manuscript)

7. Alexander GC, Casalino LP, Metlzer DO. Factors in studying patient-physician communication. JAMA. 2003;290:2544. (letter)

8. Alexander GC. Prescriptions of sleep. Canadian Family Physician. 2004;50:543-545. (essay)

9. Alexander GC. Unnecessary tests and ethics of quality of care. Virtual Mentor: Ethics Journal of the American Medical Association. Available at: http://www.ama-assn.org/ama/pub/category/12470.html Accessed June 2, 2004. (invited commentary)

10. Sayla M, Alexander GC. An annotated bibliography exploring prescription cost-sharing. Prepared for the national meeting of the Society of General Internal Medicine. June, 2005. (annotated bibliography)

11. Alexander GC. Issue brief: Many physicians engaged in addressing health disparities. Developed on behalf of the Commission to End Health Disparities, April 2005. (issue brief)

12. Alexander GC. Geographic barriers and access to care. Virtual Mentor: Ethics Journal of the American Medical Association. 2005;7. Available at: http://www.ama-assn.org/ama/pub/category/15218.html Accessed July 5, 2005. (invited commentary).

18

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13. Alexander GC. A crash course? What happens when a patient’s medical and economic best interests collide? Virtual Mentor: Ethics Journal of the American Medical Association. 2006;8:147-149. Available at: http://www.ama-assn.org/ama/pub/category/15954.html Accessed March 1, 2006. (invited commentary)

14. Smith PJ, Alexander GC, Siegler M. Should editorials in peer-reviewed journals be signed? Chest. 2006;129:1395-1396. (invited editorial)

15. Alexander GC, Lantos JD. Bioterrorism, public service, and the duty to treat. Cambridge Quarterly. 2006;15:422-423. (invited commentary)

16. Torke AM, Alexander GC. Can healers have private lives? Virtual Mentor: Ethics Journal of the American Medical Association. 2006;8:441-448. Available at: http://www.ama-assn.org/ama/pub/category/16375.html Accessed July 26, 2006. (invited commentary)

17. Alexander GC, Lantos J. The nuances of self-disclosure. Response to: “Physician self-disclosure in primary care visits: enough about you, what about me?” Arch Intern Med. 2008;168:242-244. (letter)

18. Torke A, Alexander GC, Lantos J, Siegler M. Response to letter regarding “The doctor-surrogate relationship.” Archives of Internal Medicine. 2008;168:241-242. (letter)

19. Alexander GC. Dilemmas for a reason. Journal of Clinical Ethics. 2008;19:70-71. (invited commentary)

20. Lale A, Alexander GC. The Urban Health Initiative: a story of one academic medical center and the underserved. SGIM Forum. December 2008. (invited editorial)

21. Torke AM, Alexander GC, Lantos J. Substituted judgment. Journal of General Internal Medicine. 2009;24:146. (letter to editor, reply).

22. Saunders M, Alexander GC. Turning and churning: loss of health insurance among adults in Medicaid. Journal of General Internal Medicine. 2009;24:133-4. (invited editorial)

23. Walton SM, Schumock GT, Lee KV, Alexander GC, Meltzer D, Stafford RS. Importance of distinguishing supported and unsupported off-label use. Archives of Internal Medicine. 2010;170:657-658. (Letter to editor, reply)

24. Qato DM, Alexander GC. Response to: Hartung DM, Evans D, Haxby DG, Kraemer DF, Andeen G, Fagnan LJ. Effect of Drug Sample Removal on Prescribing in a Family Practice Clinic Ann Fam Med 2010 8:402-409. (letter to editor, reply)

25. Alexander GC. Clinical prescribing (and off-label use) in a second-best world. Medical care. 2010;48:285-287. (invited editorial)

26. Health IQ:2011. The Frontiers of Healthcare Advancement. IMS Institute for Healthcare Informatics. Diffusion of Innovation: Patterns and Effects. (Invited Chapter).

27. Alexander GC. Researcher’s Corner: Talk Early and Often. SGIM Forum. 2011;34:5.

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George Caleb AlexanderBloomberg School of Public Health

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Cardiovascular risks associated with clarithromycinIyer, G. & Alexander, G. C. Jan 14 2016 In : BMJ (Online). 352, i23Article

1995 2016

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Clarithromycin

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Changes in prescription and over-the-counter medication and dietarysupplement use among older adults in the United States, 2005 vs 2011Qato, D. M., Wilder, J., Schumm, L. P., Gillet, V. & Alexander, G. C. Apr 1 2016 In : JAMA Internal Medicine.176, 4, p. 473-482 10 p.Article

Editorialists' reply to BlakeIyer, G. & Alexander, G. C. Mar 8 2016 In : BMJ (Online). 352, i1345Article

Effect of a "pill mill" law on opioid prescribing and utilization: The case ofTexasLyapustina, T., Rutkow, L., Chang, H. Y., Daubresse, M., Ramji, A. F., Faul, M., Stuart, E. A. & Alexander, G. C.Feb 1 2016 In : Drug and Alcohol Dependence. 159, p. 190-197 8 p.Article

Maximizing the Post-Approval Safety of Flibanserin: A Role for Regulators,Clinicians, and PatientsBaksh, S. N., Gellad, W. F. & Alexander, G. C. Jan 21 2016 In : Drug Safety. p. 1-6 6 p.Article

Prescriptions, nonmedical use, and emergency department visits involvingprescription stimulantsChen, L. Y., Crum, R. M., Strain, E. C., Caleb Alexander, G., Kaufmann, C. & Mojtabai, R. Mar 1 2016 In :Journal of Clinical Psychiatry. 77, 3, p. e297-e304Article

Dietary Supplements Prescriptions Drug Interactions Pharmaceutical Preparations Fish Oils

Analgesics, Opioid Prescriptions Confidence Intervals Morphine Pain Clinics

United States Food and Drug Administration Safety flibanserin Pharmaceutical Preparations

Food

Prescriptions Emergency Service, Hospital Methylphenidate Therapeutics Dextroamphetamine

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Primary care physicians' knowledge and attitudes regarding prescriptionopioid abuse and diversionHwang, C. S., Turner, L. W., Kruszewski, S. P., Kolodny, A. & Caleb Alexander, G. Mar 4 2016 In : ClinicalJournal of Pain. 32, 4, p. 279-284 6 p.Article

2015

Adherence to a novel oral anticoagulant among patients with atrialfibrillationZhou, M., Chang, H. Y., Segal, J. B., Alexander, G. C. & Singh, S. 2015 In : Journal of Managed CarePharmacy. 21, 11, p. 1054-1062 9 p.Article

Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban,and warfarin: Population based cohort studyAbraham, N. S., Singh, S., Caleb Alexander, G., Heien, H., Haas, L. R., Crown, W. & Shah, N. D. Apr 24 2015 In: BMJ (Online). 350, h1857Article

Comparing employer-sponsored and federal exchange plans: Widevariations in cost sharing for prescription drugsButtorff, C., Andersen, M. S., Riggs, K. R. & Caleb Alexander, G. 2015 In : Health Affairs. 34, 3, p. 467-476 10p.Article

Physicians, Primary Care Prescriptions Analgesics, Opioid Physicians Morbidity

Atrial Fibrillation Anticoagulants dabigatran Health Antithrombins

Warfarin Cohort Studies Hemorrhage Population Atrial Fibrillation

Cost Sharing Prescription Drugs Pharmaceutical Preparations Health Insurance Exchanges

Names

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Construct validity and factor structure of survey-based assessment of cost-related medication burdenBurcu, M., Alexander, G. C., Ng, X. & Harrington, D. Feb 2 2015 In : Medical Care. 53, 2, p. 199-206 8 p.Article

Cost Containment and Patient Well-BeingRiggs, K. R. & Alexander, G. C. Jun 26 2015 In : Journal of General Internal Medicine. 30, 6, p. 701-702 2 p.Article

Effect of direct-to-consumer advertising on asthma medication sales andhealthcare useDaubresse, M., Hutfless, S., Kim, Y., Kornfield, R., Qato, D. M., Huang, J., Miller, K., Emery, S. L. & Alexander,G. C. Jul 1 2015 In : American Journal of Respiratory and Critical Care Medicine. 192, 1, p. 40-46 7 p.Article

Effect of Florida's Prescription Drug Monitoring Program and pill mill lawson opioid prescribing and useRutkow, L., Chang, H. Y., Daubresse, M., Webster, D. W., Stuart, E. A. & Alexander, G. C. Oct 1 2015 In :JAMA Internal Medicine. 175, 10, p. 1642-1649 8 p.Article

Emergency department visits by children and adolescents for antipsychoticdrug adverse eventsHampton, L. M., Daubresse, M., Chang, H. Y., Alexander, G. C. & Budnitz, D. S. Mar 1 2015 In : JAMAPsychiatry. 72, 3, p. 292-294 3 p.

Medicare Costs and Cost Analysis Medication Adherence Behavior Health

Cost Control

Asthma Delivery of Health Care Prescriptions Emergency Service, Hospital Outpatients

Prescription Drugs Drug Monitoring Analgesics, Opioid Morphine Prescriptions

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Article

Evaluation of flibanserin science and advocacy at the FDAGellad, W. F., Flynn, K. E. & Alexander, G. C. Sep 1 2015 In : Journal of the American Medical Association.314, 9, p. 869-870 2 p.Article

How do payers respond to regulatory actions? The case of bevacizumabDusetzina, S. B., Ellis, S., Freedman, R. A., Conti, R. M., Winn, A. N., Chambers, J. D., Alexander, G. C.,Huskamp, H. A. & Keating, N. L. Jul 1 2015 In : Journal of Oncology Practice. 11, 4, p. 313-318 6 p.Article

Impact of abuse-deterrent OxyContin on prescription opioid utilizationHwang, C. S., Chang, H. Y. & Alexander, G. C. Feb 1 2015 In : Pharmacoepidemiology and Drug Safety. 24,2, p. 197-204 8 p.Article

Impact of Out-of-Pocket Spending Caps on Financial Burden of those withGroup Health InsuranceRiggs, K. R., Buttorff, C. & Alexander, G. C. May 1 2015 In : Journal of General Internal Medicine. 30, 5, p.683-688 6 p.Article

Most primary care physicians are aware of prescription drug monitoring

Emergency Drugs Antipsychotic Agents Emergency Service, Hospital

Medicare Breast Neoplasms United States Food and Drug Administration Lung Neoplasms

Insurance Carriers

Oxycodone Pharmacoepidemiology Analgesics, Opioid Prescriptions Health

Insurance, Health Delivery of Health Care Health Insurance Exchanges

Patient Protection and Affordable Care Act Insurance Benefits

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programs, but many find the data difficult to accessRutkow, L., Turner, L., Lucas, E., Hwang, C. & Caleb Alexander, G. 2015 In : Health Affairs. 34, 3, p. 484-492 9p.Article

National trends in ambulatory oral anticoagulant useBarnes, G. D., Lucas, E., Alexander, G. C. & Goldberger, Z. D. Dec 1 2015 In : American Journal of Medicine.128, 12, p. 1300-1305e5Article

National trends in the ambulatory treatment of hypertension in the UnitedStates, 1997-2012Zhou, M., Daubresse, M., Stafford, R. S. & Alexander, G. C. Mar 4 2015 In : PLoS One. 10, 3, e0119292Article

Prescription drug abuse: A national survey of primary care physiciansHwang, C. S., Turner, L. W., Kruszewski, S. P., Kolodny, A. & Alexander, G. C. Feb 1 2015 In : JAMA InternalMedicine. 175, 2, p. 302-304 3 p.Article

Racial disparities in reaching the renal transplant waitlist: Is geography asimportant as race?Saunders, M. R., Lee, H., Alexander, G. C., Tak, H. J., Thistlethwaite, J. R. & Ross, L. F. Jun 1 2015 In : ClinicalTransplantation. 29, 6, p. 531-538 8 p.Article

Prescription Drugs Physicians, Primary Care Drug Monitoring Physicians

Prescription Drug Diversion

Venous Thromboembolism Warfarin Atrial Fibrillation Anticoagulants Confidence Intervals

hypertension therapeutics Hypertension Therapeutics Antihypertensive Agents

Prescription Drugs Physicians, Primary Care Substance-Related Disorders

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Risk of gastrointestinal bleeding associated with oral anticoagulants:Population based retrospective cohort studyChang, H. Y., Zhou, M., Tang, W., Alexander, G. C. & Singh, S. 2015 In : BMJ (Online). 350, h1585Article

The Influence of Surrogate Decision Makers on Clinical Decision Makingfor Critically III AdultsShah, R. D., Rasinski, K. A. & Alexander, G. C. Jul 10 2015 In : Journal of Intensive Care Medicine. 30, 5, p.278-285 8 p.Article

The prescription opioid abuse epidemicLyapustina, T. & Alexander, G. C. Jun 13 2015 In : Pharmaceutical Journal. 294, 7866, p. 627-629 3 p.Article

The prescription opioid and heroin crisis: A public health approach to anepidemic of addictionKolodny, A., Courtwright, D. T., Hwang, C. S., Kreiner, P., Eadie, J. L., Clark, T. W. & Alexander, G. C. Mar 182015 In : Annual Review of Public Health. 36, p. 559-574 16 p.Article

The uphill battle facing antiobesity drugsDaubresse, M. & Alexander, G. C. Mar 12 2015 In : International Journal of Obesity. 39, 3, p. 377-378 2 p.Article

Geography African Americans Transplants Kidney Failure, Chronic Nuclear Family

Warfarin Anticoagulants Cohort Studies Hemorrhage Retrospective Studies

Decision Making Physicians Cardiopulmonary Resuscitation Terminal Care Critical Care

Prescriptions Analgesics, Opioid

Heroin Prescriptions Analgesics, Opioid Public Health Pain

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Trends in exposure to televised prescription drug advertising, 2003-2011Kornfield, R., Alexander, G. C., Qato, D. M., Kim, Y., Hirsch, J. D. & Emery, S. L. May 1 2015 In : AmericanJournal of Preventive Medicine. 48, 5, p. 575-579 5 p.Article

Trends in prescribing of sedative-hypnotic medications in the USA: 1993-2010Kaufmann, C. N., Spira, A. P., Alexander, G. C., Rutkow, L. & Mojtabai, R. 2015 In : Pharmacoepidemiologyand Drug Safety.Article

Trends in the use of buprenorphine by office-based physicians in theUnited States, 2003-2013Turner, L., Kruszewski, S. P. & Alexander, G. C. Jan 1 2015 In : American Journal on Addictions. 24, 1, p. 24-296 p.Article

2014

Ambulatory treatment of type 2 diabetes in the U.S., 1997-2012Turner, L. W., Nartey, D., Stafford, R. S., Singh, S. & Alexander, G. C. 2014 In : Diabetes Care. 37, 4, p. 985-9928 p.Article

Anti-Obesity Agents

Prescription Drugs Sleep Disorders Hypersensitivity Erectile Dysfunction Smoking Cessation

Pharmacoepidemiology Benzodiazepines Hypnotics and Sedatives Sleep Anxiety

Physicians' Offices Buprenorphine Analgesics, Opioid Therapeutics Physicians, Primary Care

Therapeutics Dipeptidyl-Peptidase IV Inhibitors Pharmaceutical Preparations Glucagon-Like Peptide 1

Thiazolidinediones

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Capsule Commentary on Faerber et al., Content Analysis of False andMisleading Claims in Television Advertising for Prescription andNonprescription DrugsAlexander, G. C. Jan 1 2014 In : Journal of General Internal Medicine. 29, 1, p. 180 1 p.Article

Correlates of nonmedical use of stimulants and methamphetamine use in anational sampleChen, L. Y., Strain, E. C., Alexandre, P. K., Alexander, G. C., Mojtabai, R. & Martins, S. S. May 2014 In :Addictive Behaviors. 39, 5, p. 829-836 8 p.Article

Digitalis use in contemporary clinical practice: Refitting the foxgloveGoldberger, Z. D. & Alexander, G. C. Jan 2014 In : JAMA Internal Medicine. 174, 1, p. 151-154 4 p.Article

Disposing of medicines safelyFain, K. M. & Alexander, G. C. Dec 1 2014 In : American Journal of Public Health. 104, 12, p. e2-e3Article

Emergency department visits by adults for psychiatric medication adverseeventsHampton, L. M., Daubresse, M., Chang, H. Y., Alexander, G. C. & Budnitz, D. S. Sep 1 2014 In : JAMAPsychiatry. 71, 9, p. 1006-1014 9 p.Article

Nonprescription Drugs Prescription Drugs Television Deception Capsules

Methamphetamine Pharmaceutical Preparations Prescription Drugs

Digitalis Glycosides Digitalis Cardiotonic Agents Digoxin Physician's Practice Patterns

Medication Emergency Drugs Emergency Service, Hospital

Drug-Related Side Effects and Adverse Reactions

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Impact of a drug utilization review program on high-risk use ofprescription controlled substancesDaubresse, M., Gleason, P. P., Peng, Y., Shah, N. D., Ritter, S. T. & Alexander, G. C. 2014 In :Pharmacoepidemiology and Drug Safety. 23, 4, p. 419-427 9 p.Article

Mind the gap understanding the effects of pharmaceutical direct-to-consumer advertisingFain, K. M. & Alexander, G. C. 2014 In : Medical Care. 52, 4, p. 291-293 3 p.Article

Observational study: Failure to fill a first prescription of a new medicationis common in primary care settingsHwang, C. S. & Alexander, G. C. Oct 1 2014 In : Evidence-Based Medicine. 19, 5, p. 196 1 p.Article

Physician financial incentives and care for the underserved in the UnitedStatesChien, A. T., Chin, M. H., Alexander, G. C., Tang, H. & Peek, M. E. 2014 In : American Journal of ManagedCare. 20, 2, p. 121-129 9 p.Article

Prevalence and treatment of pain in EDs in the United States, 2000 to 2010Chang, H. Y., Daubresse, M., Kruszewski, S. P. & Alexander, G. C. 2014 In : American Journal of EmergencyMedicine. 32, 5, p. 421-431 11 p.

Controlled Substances Pharmacoepidemiology Drug Utilization Review Prescriptions

State Health Plans

Patient Acceptance of Health Care Physician's Practice Patterns Physician-Patient Relations

Observational Study Prescriptions Primary Health Care

Physician Incentive Plans Vulnerable Populations Medicaid Motivation Logistic Models

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Article

Regulators should better leverage effectiveness standards to enhance drugvalueNaci, H. & Alexander, G. C. Oct 1 2014 In : Pharmacotherapy. 34, 10, p. 1005-1011 7 p.Article

Reply letter: Are FDA prescription drug safety plans working? A case studyof isotretinoinFain, K. & Alexander, G. C. 2014 In : Pharmacoepidemiology and Drug Safety. 23, 4, p. 440-441 2 p.Article

Specialty drug coupons lower out-of-pocket costs and may improveadherence at the risk of increasing premiumsStarner, C. I., Alexander, G. C., Bowen, K., Qiu, Y., Wickersham, P. J. & Gleason, P. P. 2014 In : Health Affairs.33, 10, p. 1761-1769 9 p.Article

2013

Academic Centers Play a Vital Role in the Study of Drug Safety andEffectivenessTan, J., Alexander, G. C. & Segal, J. B. Apr 2013 In : Clinical Therapeutics. 35, 4, p. 380-384 5 p.Article

Pain Management Physician's Practice Patterns Pain Measurement Analgesics

Emergency Service, Hospital

Pharmaceutical Preparations Population Characteristics Pliability Drug Therapy Therapeutics

Isotretinoin Prescription Drugs Safety

Costs and Cost Analysis Pharmaceutical Preparations Cost Sharing Drug Costs Databases

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Next ›

Ambulatory diagnosis and treatment of nonmalignant pain in the unitedstates, 2000-2010Daubresse, M., Chang, H. Y., Yu, Y., Viswanathan, S., Shah, N. D., Stafford, R. S., Kruszewski, S. P. & Alexander,G. C. Oct 2013 In : Medical Care. 51, 10, p. 870-878 9 p.Article

Are Food and Drug Administration prescription drug safety plans working?A case study of isotretinoinFain, K. & Alexander, G. C. Dec 2013 In : Pharmacoepidemiology and Drug Safety. 22, 12, p. 1258-1262 5 p.Article

Balancing burdens and benefits: Ethical issues of off-label prescriptionpharmaceutical useVox, F., Capron, A. M., Kraus, M. F., Alexander, G. C. & Kirschner, K. L. Oct 2013 In : PM and R. 5, 10, p. 882-889 8 p.Article

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Safety Pharmaceutical Preparations

Office Visits Non-Narcotic Analgesics Prescription Drugs Drug Utilization Health Care Surveys

Isotretinoin Prescription Drugs Drug Prescriptions United States Food and Drug Administration

Safety

Ethics Prescriptions

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