 2. Females must be surgically sterile hysterectomy andor bilateral oophorectomy, post-menopausal for 1 year with follicle-stimulating hormone FSH in menopausal range, or agree to use 2 medically accepted, effective methods of birth control e.g., hormonal contraception, including oral, implantpatch, or injection, or latex condom with spermicide, diaphragm with intravaginal spermicide, cervical cap with spermicide, or indwelling intrauterine device from the time of signing informed consent until 2 weeks after the Follow-Up Visit. One of the birth control methods must be a barrier method; 