Women in the following categories are not considered WOCBP •Premenarchal •Premenopausal female with 1 of the following: −Documented hysterectomy −Documented bilateral salpingectomy −Documented bilateral oophorectomy Note: Documentation can come from the site personn el’s review of the participant’s medical records, medical examination, or medical history interview. •Postmenopausal female−A postmenopausal state is defined as 12 months of ame norrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, ( FSH) level > 40 mIU/mL to confirm menopause. CONTRACEPTION GUIDANCE FOR FEMALE PARTICIPANTS OF CHILD BEARING POTENTIAL One of the highly effective methods of contracep tion listed below is required during study duration and until the end of relevant systemic exposure, defined as 5 months after the end of study treatment.