 - Women of child-bearing potential and men must agree to use adequate contraception hormonal or barrier method of birth control; abstinence prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a female of child-bearing potential is any woman regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice who meets the following criteria: 