........... 56 4.7.10 Day 1 of study treatment cycle assessments ................................ ............. 56 4.7.11 End of treatment / withdrawal assessments ................................ ............... 56 4.7.12 Post treatment follow -up assessments ................................ ....................... 56 4.8 Post-study access to study treatment ................................ ......................... 56 5 SAFETY DEFINITIONS AND REPORTING REQUIREMENTS ........................... 57 5.1 Reporting of adverse events ................................ ................................ ......57 5.2 Reporting period ................................ ................................ ........................ 57 5.3 Assessment of causality ................................ ................................