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Contents of Clinical Study Report 1. TITLE PAGE 2. SYNOPSIS 3. TABLE OF CONTENTS FOR THE INDIVOrderIDUAL CLINICAL STUDY REPORT 4. LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 5. ETHICS 6. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE 7. INTRODUCTION 8. STUDY OBJECTIVES 9. INVESTIGATIONAL PLAN 10. STUDY PATIENTS 11. EFFICACY EVALUATION 12. SAFETY EVALUATION 13. DISCUSSION AND OVERALL CONCLUSIONS 14. TABLES, FIGURES, AND GRAPHS REFERRED TO BUT NOT INCLUDED IN THE TEXT 15. REFERENCE LIST 16. APPENDICES