 - 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, during the study participation, and for three months after the last dose of the drug; women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to registration and agree to use effective contraception throughout the treatment period and for 3 months after the last dose of study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception; males should avoid fathering children during and for at least three months after therapy is completed 