 - Female subjects must have a negative pregnancy test. Women of child bearing potential should have been surgically sterile for at least 6 months prior to dosing or must agree to take reasonable precautions during the study to avoid pregnancy by agreeing to remain abstinent or to practice one of the following methods of birth control from study screening through the last study visit: double barrier e.g., diaphragm with spermicide; condoms with spermicide; intrauterine device IUD; implanted or intrauterine hormonal contraceptives in use for at least 6 consecutive months prior to study dosing; or oral, patch, or injected contraceptives or vaginal hormonal device in use for at least 3 consecutive months prior to study. 