 11. Females of childbearing potential must have a negative serum pregnancy test and must agree to use adequate contraception for the duration of the study and six months after. Females of childbearing potential are defined as those who are not surgically sterile ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy or postmenopausal defined as 12 months with no menses without an alternative medical cause. Continued in 12 