 17. Women of childbearing potential must agree to use adequate contraception hormonal or barrier method of birth control; abstinence for the duration of study participation and for six 6 months after discontinuation of the study drugs. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation, hysterectomy or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. The patient, if a man, agrees to use effective contraception or abstinence for the duration of study participation and for six 6 months after discontinuation of the study drugs. 