**Overview** The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data package contains information on medication errors, quality complaints a
*Grade 3/4 adverse events summarised by MedDRA System Organ Class which were reported by 5 or more peoplepy: person yearsClinical outcomes by randomised arm.
ADE = adverse drug event; CI = confidence interval. aAs one person could have multiple ADEs, the combined prevalence is lower than the sum of the prevalences of the ADE categories. bSelf-reported use
