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Marco Tuccori is an Editorial Board member of Drug Safety. Marco Tuccori was not involved in the selection of peer reviewers for the manuscript nor in any of the subsequent editorial decisions.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"This study was based on data from publicly available, anonymized reports. Ethical approval was not required.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Row data used for this study are publicly accessible at","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability statement"}},{"value":"Custom codes are available upon reasonable request to the authors.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"GR, MT and RG conceived and designed the study. FF conducted the management and analysis of data. GR and LP conducted the case-by-case causality assessment. All authors contributed to the interpretation of the study results. GR drafted the manuscript. All authors contributed substantially to the revision of the manuscript.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}