• Patient not expected to survive 28 days because of an uncorrectable medical condition, such as poorly controlled neoplasm or other end-stage disease. • Moribund state in which death is perceived to be imminent. • Human immunodeficiency virus infection in association with a last known CD4 cell count ≤ 50/mm 3 . • History of bone marrow, lung, liver, pancreas, or smallbowel transplantation. • Chronic renal failure requiring hemodialysis or peritoneal dialysis (acute renal failure was not an exclusion criterion). • Known or suspected portosystemic hypertension, chronic jaundice, cirrhosis, or chronic ascites. • Acute pancreatitis with no established source of infection.