 - Study participants who 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; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids with minimal systemic absorption; physiologic replacement doses of systemic corticosteroids are permitted, even if 10 mgday prednisone equivalents; a brief course of corticosteroids for prophylaxis e.g., contrast dye allergy or for treatment of non-autoimmune conditions e.g., delayed-type hypersensitivity reaction caused by contact allergen is permitted 