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Marian Attalla is currently employed by PharmaRelations; however, her contributions to this work were made prior to the start of the employment at PharmaRelations and as part of her employment at the Uppsala Monitoring Centre. No changes to the article have been made based on her comments since the start of the employment at PharmaRelations.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The reports shared within the World Health Organization Programme are deidentified, and research based on these data is not subject to ethics approval or informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The datasets generated and analysed during the current study are not publicly available because of agreements between contributors of data to the database used (VigiBase) and the custodian of this database. National centres (mainly national drug regulatory authorities) constituting the World Health Organization Programme for International Drug Monitoring contribute data to VigiBase and the Uppsala Monitoring Centre is the custodian in its capacity as the World Health Organization Collaborating Centre for International Drug Monitoring. Some subsets of the data may be available from the corresponding author on reasonable request.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"Sarah Watson wrote the draft and performed analyses. Henric Taavola, Marian Attalla and Elenor Kaminsky performed analyses and provided critical reviews and editing to the manuscript. Qun-Ying Yue contributed with conceptualisation, methodology, critical review and editing to the manuscript. All authors read and approved the final version.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 contributions"}}]}}