- Female subjects of childbearing potential must not become pregnant during the study period, thus, should be sexually inactive through abstinence or use of contraceptive methods the failure rate <1%. Inactivity sexual abstinence should be consistent with the usual lifestyle of the subject. Periodic abstinence and withdrawal are not acceptable methods of contraception. Will be accepted as methods of contraception with failure rate less than 1%: oral contraceptives, either combined or progestogen alone, injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, Percutaneous contraceptive patches, intrauterine device (IUD) or intrauterine system (IUS ) that meets the failure rate <1%, double barrier method, partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject;