Background

11/8/01


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Table of Contents

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Background

Background (cont)

Results of 5-day Studies

Results of 5-day Studies (cont)

Results of 5-day Studies (cont) Bacteriologic -Study 176

Results of 5-day Studies (cont)

Results of 5-day Studies (cont) Bacteriologic -Study 128

Comparison of Exposure Among Azithromycin Regimens

Comparison of Exposure Among Azithromycin Regimens (cont)

Pivotal Studies

Study 1014

Description

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Study R-0581

Description

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Study R-0581: Clinical Outcome by Age at TOC (MITT Population)

Study 1015

Description

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Study 1015: Clinical Outcomes by Age at TOC (MITT Population)

Study 1015: Clinical Outcome By Baseline Pathogen at EOT

Study 1015: Clinical Outcome By Baseline Pathogen at TOC

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Study 95-001

Description

Study 95-001: Clinical Outcome by Baseline Pathogen at EOT (MITT Population)

Summary of Clinical Outcome TOC

Summary of Bacteriological Outcome (Study1015)

Published Studies

Published Studies

Safety

All Adverse Events for AOM Studies Only

% (n/N) of Subjects Reporting Vomiting by Day and Treatment Group for AOM Studies Only

Acknowledgments

Author: CDER USER