GPT and kidney disorder: Grade 3 or above TRAEs occurred in 13 (36%) of subjects, including lipase increased (n = 4), anemia (n = 3), hypokalemia (n = 2), direct bilirubin (DBIL) increased (n = 2), and one occurrence each of ALT increased, amylase increased, proteinuria, creatine kinase increased, serum creatinine increased, hyperglycemia, low blood pressure, and kidney disease (Additional file 1: Table S2).