- A female subject is eligible to participate if she is of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or bilateral oophorectomy or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. If the clinical situation is unclear, FSH and estradiol levels may be used to confirm post-menopausal status at Screening. Simultaneous follicle stimulating hormone (FSH) > 40 mIU/ml and estradiol < 40pg/ml (<140pmol/L) is confirmatory in the absence of a clear post-menopausal history.