 - Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural spontaneous amenorrhea with an appropriate clinical profile e.g. age appropriate, history of vasomotor symptoms or six months of spontaneous amenorrhea with serum follicle stimulating hormone FSH levels 40 mIUmL for United States US only: and estradiol 20 pgmL or have had surgical bilateral oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential 