 - Male and female subjects of child-bearing potential must be willing to practice effective birth control for the duration of the study. Female subjects must be: 1 postmenopausal for at least 12 months, 2 surgically sterile, or 3 willing to use 2 documented forms of birth control e.g., barrier and spermicide, intrauterine device and barrier or spermicide, or birth control pill and barrier or spermicide. 