11. inclusion 9 continued: b) A highly effective method of contraception is defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly. The acceptable methods of contraception are: Barrier Method (e.g. male condom with spermicide, copper T intrauterine device, or levonorgestrel-releasing intrauterine system - Mirena®) or Hormonal Methods (e.g. implants, hormone shot or injection, combined pill, minipill, or patch).Non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Days 1-180 post last dose. In addition, they must refrain from sperm donation for 180 days after the final dose of investigational product.