- Female patients must be non-lactating and at no risk of pregnancy for one of the following reasons: Postmenopausal (amenorrhea for at least 1 year); post hysterectomy and/or post-bilateral ovariectomy; if of childbearing potential, having a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test at screening and is using a highly effective method of birth control throughout the study; reliable sexual abstinence throughout the course of the study is acceptable as a highly effective method of birth control for the purposes of this study.