 2. All female subjects must have negative pregnancy test results at screening and baseline. Women of childbearing potential WoCBP must be using simultaneously double-barrier or two acceptable methods of contraception, e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc. Hormone replacement as either oral or implantable is acceptable as one form, from the time of screening and for the duration of the study, through study completion and for 4 months following study completion. 