 - Patients must not be pregnant or breast feeding and must have a negative pregnancy test within 14 days of the administration of the first study treatment. Further, all women of childbearing potential and sexually active males must agree to use a medically effective contraception method throughout the treatment period and avoid conception while participating in this study. Women must not be lactating. Post menopausal patients and patients who had a bilateral oophorectomy need not take a pregnancy test. 