AESIs related to hepatotoxicity and hepatobiliary disorders were experienced by four participants (n = 4/38, 11%) across three dosing groups (2.5, 5, 10 mg); for two of these participants, PCC levels for ALT, AST, total bilirubin, and/or GGT were also reported (in total there were six participants with PCC levels, four did not have a corresponding AESI). This evidence concerns the gene GPT and hepatobiliary disorder.