There were no cases of bilirubin > 2 × ULN and therefore no Hy's law cases (ie, ALT or AST > 3 × ULN + total bilirubin > 2 × ULN without cholestasis and without alternative explanation), which is used by the FDA to identify drugs likely to cause severe drug-induced liver injury.43 The observed elevations in ALT/AST were transient regardless of treatment duration; levels returned to baseline following discontinuation of treatment and trended toward baseline values in those participants who remained on treatment. Here, GPT is linked to cholestasis.