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Manfred Hauben is employee of Merck Healthcare KGaA, Darmstadt, Germany, and owns stock\/stock options in Merck KGaA and other pharmaceutical companies. Rave Harpaz and Robert Weber are employees of Oracle Health (US and Germany), which provides the signal detection and management software used to conduct the analysis for this article.","order":2,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study makes use of VigiBase, the 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 Program for International Drug Monitoring. Subject to these conditions, data are available from Uppsala Monitoring Centre on reasonable request.","order":3,"name":"Ethics","label":"Disclaimer","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The data used for this article are based on VigiBase (see \u201cDisclaimer\u201d above). The RGPS implementation used for this article is Oracle proprietary, but the general approach can be reproduced with generally available regression techniques (following the process described in the cited white paper). One author (RW) is a full-time employee of Oracle, and another was at the time of writing (RH).","order":4,"name":"Ethics","label":"Availability of Data and Material","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":5,"name":"Ethics","label":"Ethics Approval\/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":6,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":7,"name":"Ethics","label":"Code Availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The CRediT author contribution information is as follows: Manfred Hauben: Conception, design, analysis, interpretation; drafting; critical review; final approval; accountability. Rave Harpaz: Design, data acquisition, analysis, interpretation; drafting; critical review; final approval; accountability. Robert Weber: Data acquisition, 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"}]}}