 - Female subjects of reproductive potential having reached menses, or not having reached menopause or not having undergone hysterectomy, bilateral oophorectomy, or tubal ligation who engage in sexual activity that could lead to pregnancy must agree to avoid pregnancy during the entire 42 day trial and to consistently and appropriately use at least two of the following contraception methods: condoms, diaphragm or cervical cap with spermicide, intrauterine device IUD, hormonal-based contraception. A list of acceptable methods can be found in the FDA Birth Control Guide accessible at: 