Hy’s Law criteria were used to asse

Hy’s Law criteria were used to assess the incidence of severe hepatotoxicity. A patient was considered to be a Hy’s Law case if laboratory measurements met the following criteria: peak ALT or AST > 3 x ULN and total bilirubin (TBL) ≥ 2 x ULN at any time post-baseline, with alkaline phosphatase (ALP) ≤ 2 x ULN, and lacking an underlying clinical condition. This analysis used the lab test short name variable (LBTESTCD), the numeric results (LBSTRESN), the reference range upper limit-std units (LBSTNRHI), the baseline flag (LBBLFL), visit number (VISITNUM) and study days (LBDY) from the laboratory test results (LB) dataset. Results are determined to be a baseline value if they have a "Y" in LBBLFL.