 6. Age and Reproductive Status: a Women of childbearing potential WOCBP must use methods of contraception for 30 days 5 half-lives 60 days of the study drugs. For a teratogenic study drug andor when there is insufficient information to assess teratogenicity preclinical studies have not been done, a highly effective methods of contraception failure rate of less than 1 per year is required. Highly effective birth control in this study is defined as a double barrier method. Examples include a condom with spermicide in combination with a diaphragm, cervical cap, or intrauterine device IUD. The individual methods of contraception should be determined in consultation with the investigator. b WOCBP must have a negative serum or urine pregnancy test minimum sensitivity 25 IUL or equivalent units of HCG within 24 hours prior to the start of investigational product. 