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Additionally, he is currently a consultant for Viatris in a legal case concerning a topic not related to the content of this paper. Gianluca Trifir\u00f2 is Editorial Board member of\n                      Drug Safety\n                      , but was not involved in the selection of peer reviewers for the manuscript nor in any of the subsequent editorial decisions. Emmanuele A. Jannini is or has been a consultant and\/or paid speaker for Bayer, Ibsa, Kanna, Menarini, Mia, Otsuka, Pfizer, Recordati, Shionogi and Viatris. Erich Seifritz has received educational grants, consulting fees and lecture honoraria from Janssen Cilag, Lundbeck, Angelini, Otsuka, Servier, Ricordati, Vifor, Sunovion, Schwabe and Mepha. Georgios Schoretsanitis has served as a consultant for Dexcel Pharma, HLS Therapeutics, Lundbeck\/Otsuka, Roche and Thermo Fisher Scientific and has received speaker's fees from HLS Therapeutics, Lundbeck\/Otsuka, OM Suisse and Sadalax. All other authors declare that they have no competing interests.","order":1,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The analysis used data from VigiBase, which is an anonymized database and consent for publication is not applicable.","order":2,"name":"Ethics","label":"Ethics approval and consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The analysis used data from VigiBase, which is an anonymized database and consent for publication is not applicable.","order":3,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The original dataset of the current study are available in the VigiBase repository.","order":4,"name":"Ethics","label":"Availability of data and materials","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The cleaned dataset used in the analysis and the R code for the analysis is available from the corresponding author upon reasonable request.","order":5,"name":"Ethics","label":"Code availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"VigiBase, the WHO global database of ICSRs, is the source of our information. The information comes from a variety of sources, and the probability that the suspected ADR is drug related is not the same in all cases; the information does not represent the opinion of the UMC or WHO.","order":6,"name":"Ethics","label":"UMC statement","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"EP, SS, CG, GS conceived and designed the protocol. EP, EA and GS performed the search and collected the data. EP performed the statistical analysis. EP drafted the manuscript supervised by GS and CG and all other authors reviewed it critically for important intellectual content. All authors read and approved the final version. All authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.","order":7,"name":"Ethics","label":"Authors\u2019 contributions","group":{"name":"EthicsHeading","label":"Declarations"}}]}}