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Contents of Statistical Analysis Plan 1. STUDY SYNOPSIS 2. STUDY OBJECTIVES 2.1 Primary Objective 2.2 Secondary Objectives 2.3 Assessment of Objectives 2.4 Change the Primary Objective During the Conduct of the Study 3. STUDY DESIGN 3.1 General Design and Plan 3.2 Sample Size 3.3 Randomization and Blinding 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 5.6 Statistical Analytical Issues 6. EVALUATION OF DEMOGRAPHICS AND BASELINE CHARACTERISTICS 6.1 Demographics and Baseline Characteristics 6.2 Medical History and Prior Medical Therapy 6.3 Prior Therapies and Medications 7. EVALUATION OF TREATMENT COMPLIANCE AND EXPOSURE 7.1 Compliance to Study Drug and Treatment 7.2 Exposure to Study Drug 8. EVALUATION OF PHARMACOKINETICS 8.1 Evaluation of Pharmacokinetics 8.2 Pharmacokinetic Parameters 8.3 Bioequivalent 9. EVALUATION OF EFFICACY PARAMETERS 9.1 Analysis of Primary, Secondary, and Other Efficacy Endpoints 9.2 Method for Analysis of Efficacy Endpoints 10. EVALUATION OF SAFETY PARAMETERS 10.1 Adverse Events 10.2 Clinical Laboratory Evaluation 10.3 Concomitant Medications 10.4 Vital Signs and Physical Examinations 10.5 Other Safety Evaluations