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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
5.1 Independent Ethics Committee (IEC) or Institutional Review Board (IRB)
5.2 Ethical Conduct of the Study
5.3 Patient Information and Consent
6. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE
6.1 Investigator
6.2 Sponsor Study Personnel
6.3 Other Study Personnel
7. INTRODUCTION
7.1 Inclusion/Exclusion Criteria
7.2 Efficacy Assessments
8. STUDY OBJECTIVES
9. INVESTIGATIONAL PLAN
9.1 Overall Study Design and Plan: Description
9.2 Discussion of Study Design, Including the Choice of Control Groups
9.3 Selection of Study Population
9.3.1 Inclusion Criteria
9.3.2 Exclusion Criteria
9.3.3 Removal of Patients from Therapy or Assessment
9.4 Treatments
9.4.1 Treatments Administered
9.4.2 OrderIDentity of Investigational Products(s)
9.4.3 Method of Assigning Patients to Treatment Groups
9.4.4 Selection of Doses in the Study
9.4.5 Selection and Timing of Dose for Each Patient
9.4.6 Blinding
9.4.7 Prior and Concomitant Therapy
9.4.8 Treatment Compliance
9.5 Efficacy and Safety Variables
9.5.1 Efficacy and Safety Measurements Assessed and Flow Chart
9.5.2 Appropriateness of Measurements
9.5.3 Primary Efficacy Variable(s)
9.5.4 Drug Concentration Measurements
9.6 Data Quality Assurance
9.6.1 Monitoring
9.6.2 Training of Study Personnel
9.6.3 Data Management
9.6.4 Clinical Site Audit
9.7 Statistical Methods Planned in the Protocol and Determination of Sample Size
9.7.1 Statistical and Analytical Plans
9.7.1.1 Baseline Data
9.7.1.2 Compliance Data
9.7.1.3 Pharmacokinetic Variables
9.7.1.4 Efficacy Variables
9.7.1.4.1 Definitions of evaluability
9.7.1.4.2 Statistical Methods for Analysis Efficacy Data
9.7.2 Safety Variables
9.7.3 Determination of Sample Size
9.8 Changes in the Conduct of the Study or Planned Analyses