randomized
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control randomTRANSCRIPT
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Approval was based on two randomized studies involving 1234 patients, in which 70% of those who received finafloxacin otic suspension achieved clinical cure (defined as complete resolution of ear tenderness, redness, and swelling), compared with 37% of those who received the vehicle (a solution that did not contain a fluoroquinolone).[6] Adverse effects included pruritus and nausea.