7 2. PURPOSE ...................................................................................................... 11 2.1. Responsibilities ..................................................................................................................... 11 2.2. Timing of Analyses ............................................................................................................... 11 3. STUDY OBJECTIVES ................................................................................... 12 3.1. Primary Objectives ............................................................................................................... 12 3.2. Secondary Objectives ............................................................................................................ 12 3.3. Exploratory Objectives ......................................................................................................... 12 3.4. Brief Description ................................................................................................................... 12 3.5. Patient Selection ................................................................................................................... 13 3.5.1. Inclusion Criteria ............................................................................................................... 13 3.5.2. Exclusion Criteria .............................................................................................................. 16 3.6. Determination of Sample Size ............................................................................................... 17 3.6.1. Stage 1 Sample Size ........................................................................................................... 17 3.7. Treatment Assignment & Blinding ........................................................................................ 18 3.8. Administration of Study Medication ..................................................................................... 18 3.8.1. Stage 1 Study Medication Administration ............................................................................ 18 3.8.2. Stage 2 Study Medication Administration ............................................................................ 18 3.9. Study Procedures and Flowchart .......................................................................................... 18 4. ENDPOINTS .................................................................................................. 19 4.1. Primary Efficacy Endpoints .................................................................................................. 19 4.2. Secondary Efficacy Endpoints .............................................................................................. 19 4.3.