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They were not involved in the selection of peer reviewers, the review of the manuscript, or any editorial decision concerning this article. All other authors declare that they have no competing interests.","order":1,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable. The data in VigiBase are deidentified and are not considered personal data.","order":2,"name":"Ethics","label":"Ethics Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable. This study did not involve human participants.","order":3,"name":"Ethics","label":"Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":4,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All authors participated in the conceptualization and design of the study. MF led the development of the draft with contributions from JF, DS, VG, and NN. MF, JF, DS, VG, FvH, JS, LH, NN, and JE participated in focus groups to conceptualize the framework. MF and JF performed the annotation. MF performed the data analysis. All authors contributed to the review of the manuscript. All authors have read and approved the final version.","order":5,"name":"Ethics","label":"Author Contributions","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The data that support the findings of this study are not publicly available. Access to data in VigiBase is subject to the requirements of the VigiBase Data Access Conditions. For the purposes of this study, access to the data was granted following case-by-case review in accordance with those conditions (IR 00122698). Subject to these conditions, data are available upon reasonable request. For further inquiries, please contact Uppsala Monitoring Centre via\n                      \n                      .","order":6,"name":"Ethics","label":"Availability of Data and Materials","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The code used in this study is available at\n                      \n                      . For further enquiries, please contact Uppsala Monitoring Centre at\n                      \n                      .","order":7,"name":"Ethics","label":"Code Availability","group":{"name":"EthicsHeading","label":"Declarations"}}]}}