5.8.4 Baseline and Demographic characteristics 5.8.5 Analysis of Primary Efficacy Variable 5.8.6 Secondary Analyses and Analysis of Secondary Efficacy Variable 5.8.7 Analysis of Safety Variables 5.8.8 Determination of Sample Size 5.8.9 Interim Analysis Methods [if applicable] 6. INVESTIGATOR REQUIREMENTS 6.1 Study Initiation 6.2 Study Completion 6.3 Study Discontinuation 6.4 Informed Consent 6.5 Adverse Events 6.5.1 Definitions 6.5.2 Evaluating and Recording Adverse Events 6.5.3 Reporting Adverse Events 6.6 Study Monitoring 6.7 Electronic Case Report Forms 6.8 Study Drug Accountability 6.9 Confidentiality of Data 6.10 Retention of Records 6.11 Protocol Adherence 7. REFERENCES 8. APPENDICES
5.8.4 Baseline and Demographic characteristics 5.8.5 Analysis of Primary Efficacy Variable 5.8.6 Secondary Analyses and Analysis of Secondary Efficacy Variable 5.8.7 Analysis of Safety Variables 5.8.8 Determination of Sample Size 5.8.9 Interim Analysis Methods [if applicable] 6. INVESTIGATOR REQUIREMENTS 6.1 Study Initiation 6.2 Study Completion 6.3 Study Discontinuation 6.4 Informed Consent 6.5 Adverse Events 6.5.1 Definitions 6.5.2 Evaluating and Recording Adverse Events 6.5.3 Reporting Adverse Events 6.6 Study Monitoring 6.7 Electronic Case Report Forms 6.8 Study Drug Accountability 6.9 Confidentiality of Data 6.10 Retention of Records 6.11 Protocol Adherence 7. REFERENCES 8. APPENDICES
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