4. For women: Postmenopausal for at least 1 year before the screening visit, OR surgically sterile, OR if they are of childbearing potential, agree to practice 1 effective methods of contraception, and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 180 days (or longer, as mandated by local labeling [eg, USPI, SmPC, etc.])after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (Periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicide only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)