9. Women of childbearing potential must have a negative serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. Female patients of child bearing potential and their partners, who are sexually active, must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for at least 1 month after last dose of study drug. Males patients, who are sexually active, must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for at least 3 month after last dose of study drug. Acceptable birth control methods are described in appendix 10.