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Clinical Pharmacokinetic Noncompartmental Data Analysis Plan

- i - PRIVILEGED AND CONFIDENTIAL COMMUNICATION Clinical RESEARCH IN INFECTIOUS DISEASES Clinical Pharmacokinetic Noncompartmental data Analysis Plan For DMID Protocol: 16-0118 Study Title: A Phase 1 Clinical Trial to Evaluate the Plasma Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Zoliflodacin in Healthy Male and Female Subjects Version DATE: 03 April 2018 Prepared and Distributed by: The Emmes Corporation Rockville, Maryland USA THIS COMMUNICATION IS PRIVILEGED AND CONFIDENTIAL The Emmes Corporation Version Noncompartmental Pharmacokinetic Analysis Plan DMID Protocol: 16-0118 03 April 2018 - ii - PRIVILEGED AND CONFIDENTIAL COMMUNICATION TABLE OF CONTENTS ACRONYMS AND ABBREVIATIONS ..III 1. PREFACE ..1 2. Clinical STUDY METHODS ..2 Analysis Groups.

Data Analysis Plan For DMID Protocol: 16-0118 Study Title: A Phase 1 Clinical Trial to Evaluate the Plasma Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Zoliflodacin in Healthy Male and Female Subjects Version 1.0 DATE: 03 April 2018 Prepared and Distributed by: The Emmes Corporation Rockville, Maryland USA

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clinicaltrials.gov

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