GPT and hyperamylasemia: Five grade 4 events were reported during the trial as follows: diarrhea (4.5 MIU), pancreatitis (7.5 MIU), abdominal pain with hyperamylasemia (7.5 MIU), elevated alanine aminotransferase (4.5 MIU), and abdominal cramps with diarrhea (control).