 5. Women of childbearing potential must be using at least one form of medically acceptable contraception i.e. either oral, topical, implanted hormonal contraceptives, or an intrauterine device or two barrier methods; have a negative pregnancy test at Screening and BaselineDay 1 and agree to use reliable methods of contraception until at least 24-hours after the last dose of study drug. Women who are surgically sterile i.e. hysterectomy, bilateral oophorectomy, or tubal ligation or those who are post-menopausal for at least 2 years are not considered to be of childbearing potential. Men who are not sterile i.e. have not had a vasectomy must also agree to use contraception until at least 24-hours after the last dose of study drug. 