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Article History

Accepted: 13 February 2024

First Online: 9 May 2024

Declarations

:

: The trials were funded by Novo Nordisk.

: Hanne Haahr, Janne R. Hingst, Shan Jiang, Niels R. Kristensen and Lea Nørgreen are employees and shareholders of Novo Nordisk. Blanka Cieslarová, Viera Kupčová, Frank-Dietrich H. Wagner and Stanislav Ignatenko have no conflicts of interest that are directly relevant to the content of this article.

: The trials were approved by the respective local independent ethics committees (Ethik-Kommission des Landes Berlin, Berlin, Germany; BSK Ethics Commission, Bratislava, Slovakia; and Ethics Committee IKEM and TNsP, Prague, Czech Republic) and were performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments.

: Informed consent was obtained from all individual participants included in the trials.

: Not applicable.

: 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 European Union and USA will be shared. Trial protocols and redacted clinical trial reports 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 the European Union and USA. There is no end date. Data will be shared with bona fide 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.

: Not applicable.

: HH contributed with conception and design of trials, critical manuscript revision and final manuscript approval. BC, VK, F-DHW and SI contributed with trial design, data collection, critical manuscript revision and final manuscript approval. JRH contributed with trial design, data analysis, critical manuscript revision and final manuscript approval. SJ, NRK and LN contributed with data analysis, critical manuscript revision and final manuscript approval.