................................ ...60 5.6.2 Hospitalization - Prolongation of existing hospitalization ........................ 61 5.6.3 Serious Adverse Events related to study -mandated procedures ................ 61 5.7 Reporting of serious and non -serious adverse events ............................... 62 5.7.1 Reporting requirements ................................ ................................ ............. 62 5.7.2 Serious adverse event reporting requirements ................................ ........... 62 5.8 Management of adverse events, dosing adaptations and risk minimization strategy ................................ ................................