AEs leading to discontinuation were ALT elevation, increased bilirubin levels (attributed to preexisting Gilbert's syndrome; peak total bilirubin of 104.3 μmol/L) and diarrhea/nausea/backache/fatigue in the core 10 mg/kg/day cohort (n = 1 for each); severe rash, serum creatinine elevation, nausea, and ALT elevation in the core 15 mg/kg/day cohort (n = 1 for each); and diarrhea and increased levels of serum aminotransferases in the extension 15 mg/kg/day cohort (n = 1 for both). Here, GPT is linked to Gilbert syndrome.