 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 have had surgical bilateral oophorectomy with or without hysterectomy or tubal ligation at least six weeks prior to screening. In the case of 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. 