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This trial was funded by Novo Nordisk.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Leona Plum-M\u00f6rschel received travel grants and\/or speaker fees from Eli Lilly, Gan & Lee Pharmaceuticals and Novo Nordisk. Solvejg Hansen is an employee of Novo Nordisk. Lizette Ravn Andersen, Niels Rode Kristensen, Lars Lang Lehrskov and Hanne Haahr are employees and shareholders of Novo Nordisk. Ulrike H\u00f6velmann and Patricia Krawietz declare that they have no conflict of interest.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"Individual participant data will be shared in data sets in a de-identified\/anonymised format. Data sets from Novo Nordisk sponsored clinical research completed after 2001 for product indications approved in both the EU and US will be shared. Trial protocol and redacted Clinical Trial Report will be available according to Novo Nordisk data sharing commitments. The data will be available permanently after research completion and approval of product and product use in both EU and US. There is no end date. Data will be shared with <i>bona fide<\/i> researchers submitting a research proposal requesting access to data for use as approved by the Independent Review Board according to the Independent Review Board Charter (see novonordisk-trials.com). The data will be made available on a specialised SAS data platform.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Informed consent was obtained from all individual participants included in the trial.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"LP-M contributed with trial design, data collection, critical manuscript revision and final manuscript approval. LRA, LLL and NRK contributed with data analysis, critical manuscript revision and final manuscript approval. SH contributed with trial design, data analysis, critical manuscript revision and final manuscript approval. UH and PK contributed with data collection, critical manuscript revision and final manuscript approval. HH contributed with trial conception and design, critical manuscript revision and final manuscript approval.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}