 - Female subjects must be postmenopausal i.e., 6 months without menstrual period, surgically sterile, or using effective contraceptive measures oral contraceptives, Norplant, Depo-Provera, an intra-uterine device IUD, a diaphragm with spermicide or a condom with spermicide. Women of childbearing potential must use effective contraceptive measures for at least 1 month prior to visit 1a, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study medication. 