 14. Sexually active women of childbearing potential must use an effective method of birth control during the course fo the study, in a manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control. 