 - If female, patient is post-menopausal, surgically sterilized, or willing to use two acceptable methods of birth control i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide throughout the study and for 3 months from the end of the study. A condom alone is not considered an acceptable method of birth control. If male with a female partner of childbearing potential, willing to use two acceptable methods of birth control for the duration of the study. For both females and males, acceptable birth control must be used for at least 3 months after the last dose of study medication. 