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Arie Regev is an employee and shareholder of Eli Lilly and Company. Alexandre Kiazand is an employee of AstraZeneca. Mahnoush Bahjat has employment with and stock ownership in AstraZeneca. Luciana Kikuchi is an employee of Bayer. Hewei Li is an employee of Johnson & Johnson and may hold Johnson & Johnson stock. Hans Tillmann performs consulting services for Bausch Health, Novo Nordisk and Novartis, with a family employee of Abbvie, who hold stocks in Abbott, Abbvie and Gilead Sciences. Ulrike Heinzel-Pleines, Anju Garg, Ali Hamidi, David H Alpers, Dominique Larrey, Adrian M. Di Bisceglie report no conflicts of interest. James Lewis is an Editorial Board member of\n                      Drug Safety\n                      . James Lewis was not involved in the selection of peer reviewers for the manuscript nor in any of the subsequent editorial decisions.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Not applicable as this relates to literature review and expert consensus and not primary clinical trial data.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable. Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All authors made substantial contributions to the conception or design of the work, or the acquisition, analysis, or interpretation of data. AF, AR, AK, UHP, MB, AG, LK, HL and AH wrote the first draft of the manuscript. All authors reviewed and provided critical revision of the manuscript for important intellectual content. All authors read and approved the final version of the manuscript and agree to be accountable for all aspects of the work.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}},{"value":"All relevant data are included in this published article and its supplementary files.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}}]}}