- If female, and of childbearing potential, has not been consistently using effective birth control for the 28 days prior to study entry. An example of highly effective birth control is oral contraceptives, hormone implants, abstinence (confirmed by Investigator), or male condom plus spermicide. All female subjects, regardless of birth control history must provide a urine sample for pregnancy screening. Effective birth control must be used for the duration of the study. The subject must have no plan to become pregnant during the study period. Females who are post-menopausal (no spotting at all) for at least two (2) years will not require a urine pregnancy test.