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Neither of these authors were involved in the selection of peer reviewers for the manuscript or any of the subsequent editorial decisions. All other authors have no conflicts to declare.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"The data that support the findings of this study are not publicly available. Access to the data is restricted based on the conditions for access within the WHO Programme for International Drug Monitoring. Subject to these conditions, data are available from the authors on reasonable request.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Code used in the extraction and analysis of data is available upon reasonable request.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"Study conception and design: RR, EvP, CSV, NN, LS, BR, and JB. Data extraction and statistical analysis of VigiBase data: JB. Case series review: RR and EvP. Interpretation of results and preparation of draft manuscript: RR, EvP, CSV, NN, LS, BR, JB, and EH. All authors reviewed the results and approved the final version of this manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}