.5 2.1. Study Design .............................................................................................................5 2.2. Study Objectives .......................................................................................................6 3. INTERIM ANALYSES, FINAL ANALYSES AND UNBLINDING..................................74. HYPOTHESES, SAMPLE SIZE AND DECISION RULES................................................8 4.1. Statistical Hypotheses ...............................................................................................84.2. Statistical Decision Rules..........................................................................................84.3. Sample Size Determination.......................................................................................8 5. ANALYSIS SETS ............................................................................................................... ..9 5.1. Safety Anal ysis Set....................................................................................................9 5.2. Full Analysis Set .......................................................................................................95.3. Per-Protocol Analysis Set..........................................................................................95.4. Modified Intent-to-Treat Analysis Set ......................................................................95.5. Pharmacodynamics Analysis Set ..............................................................................9 5.6. Evaluable Population.................................................................................................95.7. Treatment Misallocations........................................................................................105.8. Protocol Deviations .................................................................................................10 6. ENDPOINTS AND COVARIATES ...................................................................................10 6.1. Part A Primary Endpoint.........................................................................................106.2. Part A Sec ondary E ndpoint.....................................................................................10 6.3. Part A Exploratory Endpoints .................................................................................116.4. Part B Primary Endpoint .........................................................................................126.5. Part B Secondary Endpoint .....................................................................................12 .....................................................................13 6.7. Covariates................................................................................................................