 - Is pre-menopausal with a documented bilateral tubal ligation, bilateral oophorectomy removal of the ovaries or hysterectomy, or is post-menopausal defined as 12 months of spontaneous amenorrhea. A follicle stimulating hormone FSH level will be performed to confirm a post-menopausal status. For this study, FSH levels 40 MlUml is confirmatory. 