 9. Male or Female patients 18 years or older who: a Are postmenopausal for at least 1 year before the screening visit, OR; b Are surgically sterile, OR; c If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR ; d Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence eg, calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception.; Male patients, even if surgically sterilized ie, status post-vasectomy, must agree to one of the following: e Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR; 