<qa>  What is the method of birth control?- Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception hormonal or barrier method of birth control; abstinence prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating and the study physician immediately. Urine pregnancy testing will be done throughout the trial for women of childbearing potential. 