8. Male patients, even if surgically sterilized (ie, status post vasectomy),must agree to one of the following: Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study treatment, OR * Must also adhere to guidelines of any treatment-specific pregnancy prevention program, if applicable, OR *Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)