10. Patients who are of child-bearing potential (males and females) using an effective method of contraception during the treatment period and for at least 6 months after the last dose of treatment and patients who are not of child-bearing potential (males and females, e.g.post menopause). Women of child-bearing potential must have a negative serum pregnancy test just prior to first treatment. The study will provide a barrier method (e.g. condoms, etc).