 1. Have two negative pregnancy tests as verified by the investigator prior to starting any IP therapy: serum pregnancy test at screening and negative serum or urine pregnancy test investigators discretion within 72 hours prior to starting treatment with IP Cycle 1, Day 1. They must agree to ongoing pregnancy testing during the course of the study before beginning each subsequent cycle of treatment, and after the last dose of any IP. This applies even if the subject practices complete abstinence2 from heterosexual contact. 