Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment - related complications. 2. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma). 3. History of organ transplant requiring immunosuppression. 4. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis). 5.