11. males will either be sterile or agree to use, from Check-in (Day -1) of Period 1 until 90 days following Study Completion (Day 22)/ET, one of the following approved methods of contraception: male condom with spermicide; sterile sexual partner; or use by female sexual partner of an IUD with spermicide; a female condom with spermicide; a contraceptive sponge with spermicide; an intravaginal system; a diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives. Subjects will refrain from sperm donation from Check-in (Day -1) of Period 1 until 90 days following Study Completion (Day 22)/ET;