4. Medical History and Concurrent Diseases: a) Autoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease are excluded from this study as are subjects with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]). Subjects with motor neuropathy considered of autoimmune origin (eg, Guillain-Barre Syndrome and Myasthenia Gravis) are excluded from this study. b) Any subject who has a life-threatening condition that requires high-dose immunosuppressant(s). c) Presence of known HIV, hepatitis B or hepatitis C infection, regardless of control on antiviral therapy. d) Subjects with melanoma who have another active, concurrent, malignant disease with the exception of subjects with adequately treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix.