 7. Age and Reproductive Status: c Women must not be breastfeeding. d Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1 per year. The investigator shall review contraception methods and the time period that contraception must be followed. Men that are sexually active with WOCBP must follow instructions for birth control for a period of 90 days plus the time required for the investigational drug to undergo 5 half-lives 60 days. 