 OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Double barrier method, Hormonal contraceptives including oral contraceptives, hormone birth control patch Ortho Evra, vaginal contraceptive ring NuvaRing, injectable contraceptives Depo-Provera, Lunelle, or hormone implant Norplant System, Intrauterine devices, Vasectomy of partner, Non-heterosexual lifestyle 