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Informed consent was obtained from all individual participants included in the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval and informed consent"}},{"value":"This investigation was funded by Novo Nordisk.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Hanne Haahr and Lars Erichsen are employees and shareholders of Novo Nordisk. Theis Gondolf is an employee of Novo Nordisk. Thomas R. Pieber has received research support from AstraZeneca and Novo Nordisk, has served in advisory panels for AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Novo Nordisk and Roche Diabetes Care, and is an employee of CBmed - Center for Biomarker Research in Medicine (a publically funded research centre). Chantal Mathieu serves or has served on advisory panels for Novo Nordisk, Sanofi, Merck Sharp and Dohme, Eli Lilly, Novartis, Bristol-Myers Squibb, AstraZeneca, Pfizer, Janssen Pharmaceuticals, Boehringer Ingelheim, Hanmi Pharmaceuticals, Roche Diagnostics, Medtronic, Mannkind, Intrexon, Dianax and UCB, and as a speaker for Novo Nordisk, Sanofi, Merck Sharp and Dohme, Eli Lilly, Boehringer Ingelheim, AstraZeneca and Novartis. Financial compensation for these activities has been received by KU Leuven. KU Leuven has received research support for Chantal Mathieu from Medtronic, Novo Nordisk, Sanofi, Merck Sharp and Dohme, Eli Lilly, Roche Diagnostics, Abbott, Intrexon and Novartis. Tim Heise is a shareholder of Profil, which has received research funds from Adocia, Boehringer Ingelheim, Dance Pharmaceuticals, Eli Lilly, Johnson & Johnson, MedImmune, Merck Sharp and Dohme, Mylan, Nordic Bioscience, Novo Nordisk, Poxel, Roche Diagnostics, Saniona, Sanofi, Senseonics and Zealand Pharma. In addition, Tim Heise is member of advisory panels for Novo Nordisk and Mylan and received speaker honoraria and travel grants from Dexcom, Eli Lilly, Mylan, Novo Nordisk, Sanofi and Zealand Pharma. Masanari Shiramoto has no conflicts of interest to declare.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"<i>Will individual participant data be available (including data dictionaries)?<\/i> Individual participant data will be shared in datasets in a de-identified\/anonymised format. <i>What data in particular will be shared?<\/i> Datasets from Novo Nordisk-sponsored clinical research completed after 2001 for product indications approved in both the EU and USA. <i>What other documents will be available?<\/i> The study protocol and redacted Clinical Study Report (CSR) will be available according to Novo Nordisk data sharing commitments. <i>When will data be available (start and end dates)?<\/i> The data will be available permanently after research completion and approval of product and product use in both the EU and USA. There is no end date. <i>With whom will data be shared?<\/i> With bona fide researchers submitting a research proposal requesting access to data. <i>For what types of analyses?<\/i> For use as approved by the Independent Review Board (IRB) according to the IRB Charter (see novonordisk-trials.com). <i>By what mechanism will data be made available?<\/i> Access request proposal form and the access criteria can be found at novonordisk-trials.com. The data will be made available on a specialised SAS<sup>\u00ae<\/sup> data platform.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}}]}}