 8. Women who are pregnant or breast feeding or women of childbearing potential WOCBP not using an effective method of birth control. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months i.e., who has had menses any time in the preceding 12 consecutive months. Women of childbearing potential must have a negative serum pregnancy test at screening and at baseline. 