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3. STUDY DESIGN 3.1 General Design and Plan 3.2 Sample Size 3.3 Randomization and Blinding 3.3.1 Using P-values to Assess Randomisation 3.3.2 Blinding 3.3.3 Discussion of Blinding Procedure 3.4 Study Assessments 4. STUDY POPULATIONS 4.1 Subject Disposition 4.2 Definition of Populations for Analysis 4.3 Efficacy Evaluable 4.4 Intent-to-treat (ITT) 4.5 Per Protocol (PP) 4.6 Safety Population 4.7 Major Protocol Deviations 4.8 Definition of Sub-Group Population in Different Analyses 5. STATISTICAL ANALYSIS 5.1 General 5.2 Pooling of Sites 5.3 Interim Analyses 5.4 Time-Points For Analysis 5.5 Methods for Handling Missing Data 5.5.1 Handling of Dropouts 5.6 Statistical Analytical Issues 5.6.1 Assessment of Statistical Assumptions 5.6.2 Adjustments for Covariate 5.6.3 Multicentre Studies 5.6.4 Multiple Comparisons 5.6.5 Use of Efficacy Subset 5.6.6 Active-Control Studies Intended to Show Equivalence 5.6.7 Examination of Subgroups 6. EVALUATION OF DEMOGRAPHICS AND BASELINE CHARACTERISTICS 6.1 Demographics and Baseline Characteristics 6.1.1 Demographics Data 6.1.2 Baseline Characteristics 6.1.3 Baseline Data as Entry Criteria 6.2 Medical History and Prior Medical Therapy 6.2.1 Medical History 6.2.2 Prior Medical Therapy 6.2.3 Medical History of Other Disease or Condition 6.3 Prior Therapies and Medications 6.3.1 Prior Therapies 6.3.2 Prior Medications 7. EVALUATION OF TREATMENT COMPLIANCE AND EXPOSURE 7.1 Compliance to Study Drug and Treatment 7.1.1 Compliance to Study Drug 7.1.2 Measurement of Treatment Compliance