- Postmenopausal defined as 12 months of spontaneous amenorrhea. To confirm postmenopausal status, a blood sample for simultaneous follicle-stimulating hormone (FSH) >40 milli-international units per mililiter (mlU/mL) and estradiol <40 picogram/milliliter (pg/mL) (<147 picomole/liter [pmol/L]) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrolment.