12. Patients with hepatic dysfunction as evidenced by ALT or AST > 5 x ULN or direct bilirubin > 2.5 x ULN. [Note: for these laboratory values, one retest is allowed per visit (i.e.,screening or predose) at the central laboratory, local laboratory retest results may be used at the discretion of the medical monitor.] 13. Patients with the following active autoimmune disorders; myasthenia gravis, Addison's disease, Wegener's granulomatosis, primary biliary cirrhosis, bullous pemphigoid, autoimmune hemolytic anemia, autoimmune hepatitis, multiple sclerosis, Goodpasture's syndrome, idiopathic thrombocytopenic purpura, lupus erythematosus, dermatomyositis, polymyositis, or vasculitis.