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Ameet Sarpatwari\u2019s work is also funded by Arnold Ventures.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"The funders had no role in the study design; the collection, analysis or interpretation of data; writing the manuscript; or in the decision to submit the manuscript for publication.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Role of funders"}},{"value":"The authors declare that grants from the CIHR and Australia\u2019s NHMRC supported this work. Joel Lexchin declares payments from the CIHR, the Toronto Public Library and from lawyers acting on behalf of clients allegedly affected by adverse drug reactions. Marie L. De Bruin and Christine E. Hallgreen declare PhD grants from Novo Nordisk, Lundbeck, Ferring Pharmaceuticals, and LEO Pharma to the Copenhagen Centre for Regulatory Science. Barbara Mintzes is acting as an expert witness for Health Canada on a legal case and anticipates future payment for doing so. Sallie-Anne Pearson declares the Centre for Big Data Research in Health received funding for postmarket surveillance research, unrelated to the current study. Lorri Puil has received a Michael Smith Foundation for Health Research Reach Grant. Ameet Sarpatwari declares grants or contracts from Arnold Ventures, and the US FDA paid, to his institution, consulting fees from West Health, and payment for expert testimony from the American Civil Liberties Union (ACLU). Ingrid Sketris has received a CIHR Canadian Network for Observational Drug Effect Studies grant and a Drug Evaluation Alliance of Nova Scotia grant, as well as payment for serving as a member of the Patented Medicine Prices Review Board. Richard L. Morrow, Patrick C. Souverein, Bilal Ahmed, Elizabeth E. Roughead, Sarah Br\u00f8gger Kristiansen, Anna Kemp-Casey, Dee Mangin, Ruth Lopert, Lisa Bero, Danijela Gnjidic, and Colin R. Dormuth report no conflicts of interest and all authors declare no other relationships or activities that could appear to have influenced the submitted work.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"The authors are unable to share data used for this study due to a lack of data permissions for this purpose.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Programming code is unavailable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"Research ethics board approval was obtained from the University of British Columbia Clinical Research Ethics Board (H20-00929). In addition, the CPRD has received ethics approval from the NHS Health Research Authority to support research using anonymized patient data.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent was unnecessary as the study used only secondary administrative health data, which had been de-identified prior to data access.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"CD and RM had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Conception and design: CD, SP, BM, AK-C, RL, DM, CEH, MLDB, LP, ER, RM, IS, JL, LB, PCS, AS, BA, SBK, and DG. Acquisition, analysis or interpretation of data: CD, SP, BM, AK-C, RL, DM, CEH, MLDB, LP, ER, RM, IS, JL, LB, PCS, AS, BA, SBK, and DG. Drafting of the manuscript: RM. Critical revision of the manuscript: CD, SP, BM, AK-C, RL, DM, CEH, MLDB, LP, ER, RM, IS, JL, LB, PCS, AS, BA, SBK, and DG. Statistical analysis: CD and RM. Obtaining funding: CD, SP, BM, RL, DM, CEH, MLDB, LP, ER, IS, JL, LB, PCS, AS and DG. Supervision: CD and BM. Final approval of version to be published: CD, SP, BM, AK-C, RL, DM, CEH, MLDB, LP, ER, RM, IS, JL, LB, PCS, AS, BA, SBK, and DG. All authors agree to be accountable to all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.","order":10,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}