............................. 1 2.0 OVERALL STUDY DESIGN AND OBJECTIVES ................................ ....... 1 2.1 Trial Objectives .................................................................................. 1 2.2 Study Endpoints ................................................................................. 2 2.3 Trial Desi gn and Trial Procedures ........................................................ 3 2.4 Treatments and Assignment to Treatments .......................................... 4 2.5 Determination of Sample Size .............................................................. 4 3.0 GENERAL ANALYSIS CONVENTIONS ................................ ................... 5 3.1 General Conventions ........................................................................... 5 3.2 Trial Periods ....................................................................................... 5 3.3 Visit Windows ..................................................................................... 6 3.4 Baseline ............................................................................................. 6 4.0 ANALYSIS POPULATIONS ................................ ................................ .... 6 4.1 Intent -to-Treat Population .................................................................. 6 4.2 Per-Protocol Population (Clinical Efficacy) ............................................. 6 4.3 Per-Protocol Population (DLT Assessments) ......................................... 7 5.0 SUBJECT DISPOSITION ................................ ................................