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lALITHA SUPER SPECIALITIES HOSPITALETHICS COMMITTEE

Kothapet, GUNTUR - 522 001. A.P.

Date: 06-Aug-2010

To,

Dr. Polavarapu Veera Raghava SarmaLalitha Super Specialities Hospital (P) Ltd. Heart & Brain CentreKothapet, Guntur -522001Andhra Pradesh, India.

Ref: A randomized controlled trial of fixed - dose combination medicationand usual care in those at high risk of cardiovascular disease."UMPIRE- .use of a Multidrug eill In Reducing cardiovascular Events". ProtocolNumber: 241849" .

Sub: Ethics Committee approval for the Ammended Study documents for the abovereferenced study.

Dear Dr. Raghava Sarma,

We have received from you 09 copies of each of following study relateddocuments vide your letter dated: 30/Ju1/2010

1. •UMPIRE Study ProtocolVersion 2, dated 21 April 2010

2. Summary of changes to UMPIRE study protocol version 1.1 dated 28 Jan2010 to Version 2 dated 21 April 2010

3. Participant information sheet with informed consent formVersion 2, dated 11 May 2010 (English and Telugu)

4. Summary of changes to participant information sheet with informedconsent form version 1 dated 10 Dec 2009 to Version 2 dated 11 May 2010

5. Translation certificateDated 20 May 2010

6. DCGI approval for the conduct of UMPIRE studyDated 03 May 2010

7. Product liability InsuranceDated 07 Apr 2010

At the Ethics Committee meeting held on 06-Aug-2010, your referenced letter andthe above documents were examined and discussed. After due consideration. thecommittee has decided to approve the aforementioned study amendment under your

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direction at Lalitha Super Specialities Hospital (P) Ltd. Heart & Brain Centre,Kothapet, Guntur -522001, Andhra Pradesh, India.

The members present at the approval meeting met the requirements of the quorumset down in the EC operating procedures and as per ICH GCP & Schedule Yrequirements.

Please inform us in case any Serious Adverse Event is observed during the conductof the study and also let us have a periodic report on the progress of the studyannually.

We approve the assessments as specified in the clinical study protocol.

The members who attended the meeting held on 06-Aug-2010, at which yourproposal was discussed are listed below:

Sr. Names of members Role in EC Designations GenderNo1 Dr. C. Nageswara Rao Chairman Retired Surgeon and Male

Ex- Chairman of APmedical Council

2 Mr. M..V.Subba Rao Legal Expert Lawyer Male3 Dr. E. Krishna Murthy Member Praciticing Clinician Male4 Mr. G.Y.N. Babu Social Worker Treasurer - Indian Red Male

Cross Society5 Mr. B. Adiseshaiah Member Retd. Sub Registrar Male6 Mrs. M. Nirmala Lay Person Retd. Lecturer Female7 Dr. P. Vijaya Member Praciticing Clinician Female

Secretary

It is to be noted that neither you nor any of your proposed study team memberswere present during the decision-making procedures of the Ethics Committee.Kindly note that Dr.P.Vijaya (Wife of Dr.P.V.Raghava Sarma) who had attend themeeting but not participated in the voting process.

Date:

Yours truly,

&- ill ~YLc!b

Dr. C. Nageswara RaoChairmanLalitha Super specialities Hospital Ethics CommitteeKothapet, Guntur-S22001.