 a. Be unable to bear children have not had a period for 12 consecutive months, have had her uterus or ovaries removed, or have had a tubal ligation OR b. Have a male partner incapable of fathering a child has had a vasectomy at least 6 months prior to study entry and has had sperm counts verifying that he is no longer fertile OR c. Have a negative urine pregnancy test at screening AND d. Not have had unprotected sex within the last month AND e. If she is of childbearing potential, will strictly adhere to the following contraceptive measures during the study and for 3 months following the last dose of study medication: i. Abstain from sexual intercourse or ii. Her male partner agrees to use a condom during sexual intercourse AND iii. She agrees to use an approved method of contraception e.g., IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal implants. 