 9. Women of child bearing potential WOCBP who do not consent to using acceptable methods of contraception i.e. two of the following - oral contraception, barrier contraception, intrauterine device. For purposes of this study, WOCBP include any female who has experienced menarche, who has not undergone tubal ligation, and who is not postmenopausal. Post menopause is defined as: amenorrhea 12 consecutive months without another cause. 