 - not be of childbearing potential defined as: i. Postmenopausal for at least 12 months i.e., 2 years of amenorrhea without an alternative medical cause and a serum follicle stimulating hormone FSH level in the postmenopausal range per reference laboratory, OR ii. Surgically sterile e.g., underwent total hysterectomy, bilateral oophorectomy, or bilateral tubal ligationbilateral tubal clips without reversal operation, or otherwise incapable of becoming pregnant, OR 