Twelve patients had 12 SAEs in the placebo group that were considered treatment related (abnormal hepatic function [n = 2]; n = 1 patient each for myocardial infarction, diarrhea, aGVHD of the intestine, aGVHD of the liver, encephalitis, rhinovirus infection, sepsis, abnormal alanine aminotransferase, abnormal liver function test, and macular rash). The gene discussed is GPT; the disease is Sepsis.