Severe AEs (i.e., grade 3) included elevations in AST (18/494; 3.6%) and ALT (8/494; 1.6%), relapse of VL requiring hospitalization for the administration of amphotericin B (7/494; 1.4%), and single events of increased creatinine, increased bilirubin, injection site pain, injection site reaction, pneumonia, acute renal failure, tetany, anaemia, and anxiety. This evidence concerns the gene GPT and acute kidney injury.