- Women of childbearing potential, must have a negative serum pregnancy test at screening and Day 1, and be surgically sterile or using an acceptable method of contraception throughout the study and for 15 weeks after the last administration of investigational product. Postmenopausal patients defined as (1) aged over 45 years with at least 1 year of amenorrhea and levels of follicle stimulating hormone over 20 IU/L or (2) aged over 50 years with at least 1 year of amenorrhea.