 7. Female patients who: are postmenopausal for at leat 24 months before the screening visit, OR; Are surgically sterile, OR; If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, 28 days prior to starting study drug, during study treatment and for 28 days after the last dose of study treatment, OR agree to completely abstain from heterosexual intercourse. Male patients, even if surgically sterilized i.e., status post vasectomy, who: Agree to practice effective barrier contraception during the entire study treatment period and through 28 days after the last dose of study treatment, OR; Agree to completely abstain from heterosexual intercourse. 