................................ ....58 11.7.1 Time Period for Collecting Pregnancy Information ................................ ............................ 58 11.7.2 Action to Be Taken if Pregnancy Occurs ................................ ................................ ............ 58 11.7.3 Action to be Taken if Pregnancy Occurs in a Female Partner of a Male Study Subject .....59 11.8 Adverse Event s (AE) and Serious Adverse Events (SAE) ................................ .......................... 59 11.8.1 Definition of an AE ................................ ................................