 - Patient is a female of childbearing potential i.e., has not had a hysterectomy or bilateral oophorectomy, or is not at least two years postmenopausal, engaged in active heterosexual relations and is not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch or injectable contraceptive, double barrier method, or sexual activity restricted to vasectomized partner. 