 - History of, or available abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric including major depression, renal, andor other major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent. The Investigator must re-review the subjects medical fitness for participation and consider any diseases that would preclude treatment 