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Manfred Hauben is an employee of Merck Healthcare KGaA, Darmstadt, Germany, and owns stock\/stock options in Merck KGaA and other pharmaceutical companies. Rave Harpaz is an employee of Oracle Health (US), which provides the signal detection and management software used to conduct the analysis for this article.","order":1,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study makes use of VigiBase, the World Health Organization (WHO) global database of adverse event reports for medicines and vaccines. 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 Uppsala Monitoring Centre on reasonable request.","order":2,"name":"Ethics","label":"Disclaimer","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":3,"name":"Ethics","label":"Ethics Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":4,"name":"Ethics","label":"Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable. This study does not involve individual participants or identifiable personal data, as it focuses on the analysis of case intake processes using aggregated data and existing literature. Therefore, formal consent for publication is not required.","order":5,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"As the data used for this article are based on VigiBase (see Disclaimer above). The RGPS implementation used for this article is Oracle proprietary, but the general approach can be reproduced (following the process described in the cited White Paper).","order":6,"name":"Ethics","label":"Availability of Data and Materials","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":7,"name":"Ethics","label":"Code Availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Manfred Hauben: Conception, design, analysis, interpretation; Drafting; Critical Review; Final Approval; Accountability. Rave Harpaz: Design, analysis, interpretation; Drafting; Critical Review; Final Approval; Accountability","order":8,"name":"Ethics","label":"Author Contributions","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This content has been made available to all.","name":"free","label":"Free to read"}]}}