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Concept paper on the extrapolation of efficacy and safety in medicine development, EMA\/129698\/2012, 22\/06\/2012 (Accessible at: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/draft-concept-paper-extrapolation-efficacy-and-safety-medicine-development_en.pdf)."}],"container-title":["Advances in Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12325-024-02962-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12325-024-02962-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12325-024-02962-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,10,15]],"date-time":"2024-10-15T18:08:45Z","timestamp":1729015725000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12325-024-02962-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,6]]},"references-count":52,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2024,11]]}},"alternative-id":["2962"],"URL":"https:\/\/doi.org\/10.1007\/s12325-024-02962-2","relation":{},"ISSN":["0741-238X","1865-8652"],"issn-type":[{"value":"0741-238X","type":"print"},{"value":"1865-8652","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,6]]},"assertion":[{"value":"24 June 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 August 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 September 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Pierluigi Paggiaro received honoraria for education activities, received grants for advisory boards and education activities from AstraZeneca, Chiesi, GSK, Guidotti and Sanofi. Gabriel Garcia has received research grants from AstraZeneca, Boehringer Ingelheim, GSK, Novartis and Sanofi, and for acting as a consultant\/advisor\/speaker for AstraZeneca, GSK, Novartis, and Sanofi. Nicolas Roche is in receipt of grants from Boehringer Ingelheim, GSK, Novartis, Pfizer; personal consulting fees from AstraZeneca, Austral, Bayer, Biosency, Boehringer Ingelheim, Chiesi, GSK, Novartis, Pfizer, Sanofi, Teva; personal payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Menarini, MSD, Novartis, Pfizer, Sanofi, Teva, Zambon; and support for attending meetings and\/or travel from AstraZeneca, Chiesi, and GSK. Manish Verma, Maximilian Plank, Sean Oosterholt, Janna K. Duong, Anurita Majumdar and Oscar Della Pasqua are GSK employees and hold stocks\/shares in GSK.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest"}},{"value":"This article is based on in silico modelling and simulation and does not contain any new studies with human participants or animals performed by any of the authors. All clinical data used for the development and validation of the different models, as well as those required for re-sampling of the baseline characteristics of the virtual patient cohorts which were generated for the evaluation of the different simulation scenarios described in this study were derived from clinical trials that have been performed according to the Declaration of Helsinki and were approved by the required ethics committee(s) and\/or ethics review board(s). Re-use of the data for the purpose of the current investigation is in alignment with the terms of informed consent.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}