........ 55 8 STATISTICAL METHODS ................................ ................................ ................................ ...55 8.1 STATISTICAL HYPOTHESIS ................................ ................................ ................................ ..55 8.2 SAMPLE SIZE DETERMINATION ................................ ................................ ........................... 55 8.3 POPULATION FOR ANALYSES ................................ ................................ .............................. 56 8.4 STATISTICAL ANALYSES ................................ ................................ ................................ .....56 8.4.1 General Approach ................................ ................................ ................................ .......56 8.4.2 Analysis of Primary Efficacy Endpoints ................................ ................................ ....56 8.4.3 Analyses of Secondary Endpoint ................................ ................................ ................ 56 8.4.4 Safety Analysis ................................ ................................