 Patient or patients partner has been in a menopausal state for at least a year, is surgically sterile hysterectomy, bilateral oophorectomy, tubal ligation or vasectomy, is clinically diagnosed infertile, has a same-sex partner, is abstinent, or is willing to use effective contraceptive method for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Effective contraceptive methods are: 