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Published online 2021. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/212887s000lbl.pdf."}],"container-title":["Clinical Drug Investigation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40261-026-01602-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40261-026-01602-7","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40261-026-01602-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T21:48:18Z","timestamp":1791668898000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40261-026-01602-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,10]]},"references-count":52,"alternative-id":["1602"],"URL":"https:\/\/doi.org\/10.1007\/s40261-026-01602-7","relation":{},"ISSN":["1173-2563","1179-1918"],"issn-type":[{"value":"1173-2563","type":"print"},{"value":"1179-1918","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,10]]},"assertion":[{"value":"14 March 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"25 September 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"10 October 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"No financial support was received for the conduct of this study, or for the preparation or publication of this manuscript.","order":1,"name":"Ethics","label":"Funding","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"ER is an Editorial Board member of Clinical Drug Investigation; he was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. LGM reported receiving grants from Bayer, Daiiki-Sankyo and Boehringer Ingelheim outside the scope of the submitted work, and speaker fees from Pfizer and Bayer. The remaining authors declare that they have no competing interests that could reasonably be perceived to have influenced the work reported in this manuscript.","order":2,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":3,"name":"Ethics","label":"Ethical 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.","order":5,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The data used in this study are publicly available and were obtained from the US Food and Drug Administration Adverse Event Reporting System (FAERS). FAERS data can be freely accessed through the FDA website and include de-identified individual case safety reports. Drug-name standardisation was performed using the open-source DiAna R package (version 2.1, released June 2024) and its associated dictionary. The package information and source code are publicly available at\n                      \n                      . No restrictions apply to the availability of these data.","order":6,"name":"Ethics","label":"Availability of data and material","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":7,"name":"Ethics","label":"Code availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"PF conceived the research idea. DR, EP, ICA, AB and ER contributed to the study design. DR, ICA and PF performed the data analysis. All authors contributed to data interpretation. DR, ICA and PF drafted the manuscript, and all authors critically reviewed it for important intellectual content. All authors read and approved the final version of the manuscript.","order":8,"name":"Ethics","label":"Author\u2019s contributions","group":{"name":"EthicsHeading","label":"Declarations"}}]}}