 18. continued from above Male sterilization at least 6 months prior to screening. For female patients on the study, the vasectomized male partner should be the sole partner for that patient; Combination of any of the two following ab or ac or bc a. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy failure rate 1, for example hormone vaginal ring or transdermal hormone contraception b. Placement of an intrauterine device IUD or intrauterine system IUS c. Barrier methods of contraception: Condom or Occlusive cap diaphragm or cervicalvault caps with spermicidal foamgelfilmcream vaginal suppository. In case of use of oral contraception, women should have been stable on the same pill before taking study treatment.Note: Oral contraceptives are allowed but should be used in conjunction with a barrier method of contraception due to unknown effect of drug-drug interaction. 