 - Females of childbearing potential are defined as those who are not surgically sterile or post-menopausal i.e. patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for 12 months without an alternative medical cause. Post-menopausal status in females under 55 years of age should be confirmed with a serum follicle-stimulating hormone FSH level within laboratory reference range for postmenopausal women. 