- be either postmenopausal (defined as amenorrhea for ≥12 months with a confirmed follicle stimulating hormone [FSH] ≥40 milli International Units per milliliter [mIU/mL]), surgically sterile (defined as having undergone hysterectomy and/or bilateral oophorectomy), practice total abstinence from sexual intercourse as the preferred lifestyle (periodic abstinence is not acceptable), or agree to use an appropriate method of birth control consistently throughout the study and continue to use this method for 30 days (or 5 half-lives, whichever is longer) after study drug administration;