The overall AE profile was consistent with the product labeling for AOM 400 and oral aripiprazole and with the AE profile in the RCTs.8,9 Consistent with the known safety profile of AOM 400, none of the EPS-related TEAEs reported as akathisia were considered serious or resulted in study discontinuation, the changes in prolactin levels were not clinically relevant, a low incidence of suicidal ideation was observed, and injection site reactions were mild or absent. The gene discussed is PRL; the disease is infectious otitis media.