A woman of childbearing potential must be using two medically accepted means of contraception. This can include an oral or other hormonal contraceptive started at least 4 weeks prior to randomization plus a barrier method such as condoms or two barrier methods combined. Surgical sterilization of the subject or their partner is also considered acceptable. Hormonal therapies should be in place at least 4 weeks prior to randomization (V8). Women of childbearing potential must agree to a beta test at screening and during Visits 5, 7, 8, 9, 11 and 13 through 16.