 4. Pregnant or lactating woman. Woman of childbearing potential with either a positive or no pregnancy test at baseline. Woman men of childbearing potential not using a reliable contraceptive method. Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients must agree to continue contraception for 30 days from the date of the last study drug administration. 