Protocol Amendment
June 1999-after trial initiated
- Sponsor blinded
- Before 1st interim analysis
Primary Analytic Plan
- Elimination of PC deficiency status and septic shock as covariates from the CMH analysis
Inclusion and Exclusion Criteria
- Esophageal varices
- Cirrhosis
- Transplant patients
- Moribund patients
- Pancreatitis
- Malignancy
- Definition of OF