 13. Females of non-childbearing potential i.e., physiologically incapable of becoming pregnant, include a female who has had: a hysterectomy, a bilateral oophorectomy, a bilateral tubal ligation, or is post-menopausal. Patients not using hormone replacement therapy HRT must have experienced total cessation of menses for 1 year and be 45 years old, or in questionable cases, have a follicle stimulating hormone FSH value 40 mIUmL and an estradiol value 40pgmL. Patients using HRT must have experienced total cessation of menses for 1 year and be 45 years old, or have had documented evidence of menopause based on FSH and estradiol prior to the initiation of HRT. 