 4. Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile e.g., tubal ligation, hysterectomy for at least 90 days, or agree, from the time of signing the informed consent or 14 days prior to Baseline until Follow-up, to use TWO 2 of the following forms of contraception: a IUD with spermicide, female condom with spermicide, contraceptive sponge with spermicide, an intravaginal system, diaphragm with spermicide, cervical cap with spermicide, a male sexual partner who agrees to use a male condom with spermicide, a sterile sexual partner, OR abstinence. For all females, a pregnancy test result must be negative at Screening and BaselineDay 0 