 - Patients with a requirement for steroid treatment or other immunosuppressive treatment: patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids 10 mg daily prednisone equivalents or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease 