 - Male subjects not using adequate contraceptive methods. Male subjects have to agree to use contraception condom with spermicide in addition to having their female partner if of childbearing potential use another form of contraception eg, an intrauterine device, diaphragm with spermicide, oral contraceptive, injectables, or subdermal hormonal implant from the first dose until 4 months following the last dose administration. Also, the male subjects must not donate sperm until at least 4 months following the last dose administration. 