 - Women of childbearing potential WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization hysterectomy or bilateral oophorectomy or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone FSH level less than 40 mIUmL 