 - Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids or other systemic immunosuppressants, including oral steroids e.g., prednisone, dexamethasone or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional but not continuous use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study 