8.1.3 Discontinuation Due to Further Progression (Confirmed Progression) . 8.1.4 Post-study Treatment Study Follow-up .................................................... 8.2 Discontinuation from the Study ........................................................................ 8.3 Lost to Follow-up .............................................................................................. 9 STUDY ASSESSMENTS AND PROCEDURES ..................................................... 9.1 Efficacy Assessments ........................................................................................ 9.1.1 Methods of Assessment ............................................................................ 9.1.2 Primary Efficacy Assessments ................................................................. 9.1.3 Secondary Efficacy Assessments .............................................................. 9.2 Adverse Events ................................................................................................. 9.2.1 Time Period and Frequency for Collecting AE and SAE Information .... 9.2.2 Method of Detecting AEs and SAEs ......................................................... 9.2.3 Follow-up of AEs and SAEs ..................................................................... 9.2.4 Regulatory Reporting Requirements for SAEs ......................................... 9.2.5 Pregnancy ................................................................................................