- Female subjects of childbearing potential were to be counseled in the appropriate use of birth control while in the study. They were to be using a medically accepted method of birth control, for example: double barrier method, oral contraceptive, Depo-Provera®, or Norplant®, prior to Baseline and during the study. Women who were not sexually active were to agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study. If the subject had had a tubal ligation or was using an intra-uterine device, or if the husband/partner had had a vasectomy, another method was to be used.