 - Non-pregnant women of childbearing potential must be using a medically acceptable, adequate form of birth control. This includes: 1 hormonal contraceptive as prescribed by a physician eg, oral combined, hormonal implant, depot injectable; 2 medically prescribed IUD; 3 condom in combination with a spermicide; 4 Monogamous relationship with a male partner who has had a vasectomy or is using a condom plus spermicide during the study. They must have started this birth control method at least 3 months prior to Screening with the exception of condom in combination with a spermicide, must agree to continue its use for the duration of the study. Women of childbearing potential who are not currently sexually active must agree and consent to using a double-barrier method should they become sexually active during the course of this study. Women who are surgically sterilized or are at least 1 year postmenopausal are considered not to be of childbearing potential. However, all female subjects must have a urine pregnancy test obtained at screening, prior to initiation of treatment, at the end of the trial, which must be negative. 