......... 38 6.2.1 Phase 2 Sc hedule of Events ................................ ................................ ................................ .39 6.2.2 Phase 2 Screening Procedures ................................ ................................ ............................. 41 6.2.3 Phase 2 On -Study Procedures ................................ ................................ .............................. 41 6.3 Long -term Follow -up Visits ................................ ................................