 - using an acceptable method of birth control from screening and agree to continue to use the same method of contraception throughout the study and for 6 months after study drug administration or longer, if dictated by local regulations. Oral hormone based contraceptives are not allowed from 14 days before the planned study drug administration until 6 months after the last dose of treatment due to the potential for drug-drug interactions which might undermine their efficacy. An IUD, being either hormonal i.e., IUS or non-hormonal, is considered highly effective and reliable; therefore subjects using an IUDIUS are not required to use additional contraceptive methods no double-barrier method is required. Other non-oral hormone-based contraception methods e.g., injectable, implants, transdermal system, vaginal ring may be continued, but as the interaction of the study drug with hormone-based contraception is unknown, these methods are not considered to be reliable and therefore subjects should use a double-barrier method e.g., male condomeither diaphragm or cervical cap with or without spermicide. 