......... 32 6.1.1 Phase 1 Sc hedule of Events ................................ ................................ ................................ .33 6.1.2 Phase 1 Screening Procedures ................................ ................................ ............................. 35 6.1.3 Phase 1 On -Study Procedures ................................ ................................ .............................. 35 6.2 Phase 2 ................................ ................................ ................................ ................................