obtained registration uln days prior bilirubin creatinine total upper normal total bilirubin upper limit normal uln age range serum days conjugated sum unconjugated age bilirubin upper limit normal uln total bilirubin uln gilbert level enrolled total serum known upper limit institutional bilirubin upper total uln normal limit level days registration institutional bilirubin upper normal limit total age direct registration serum indicated renal creatinine function adequate uln insufficiency upper level limit bilirubin uln equal conjugated mla institutional needs level transaminases phase iuln bilirubin total registration direct patients days prior arm cohort administration institutional upper limit normal uln measured total bilirubin days creatine phosphokinase ck cpk uln kinase plasma normal upper limit