 4. Females of childbearing potential female subjects must have a negative pregnancy test. A woman is considered of childbearing potential unless she is permanently sterile hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy or is postmenopausal had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone FSH concentration 40 international units per litre IUL 