 9. Negative pregnancy test in females of childbearing potential FCBP. Male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 23 weeks for females or 31 weeks for males following the last dose of study medication. Acceptable forms of contraception include 1 highly effective method such as an intrauterine device IUD, hormonal birth control pills, injections, or implants, tubal ligation, or partners vasectomy and at least 1 additional approved barrier method such as a latex condom, diaphragm, or cervical cap plus spermicide. Female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test within 24 hours of the first study treatment. 