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Authors
Nguyen, Thi-Ngoc-Tu
Schubert, Melanie https://orcid.org/0000-0003-4989-5522
Mauer, René
Reuter, Marvin
Dragano, Nico
Seidler, Andreas
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Funding
Funding for this research was provided by:
Technische Universität Dresden
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Article History
Received: 22 June 2026
Accepted: 15 September 2026
First Online: 25 September 2026
Declarations
Ethical approval and consent to participate: The German National Cohort (NAKO) study is performed with the approval of the relevant ethics committees and is in accordance with national law and with the Declaration of Helsinki of 1975 (in the current, revised version). Ethics approvals issued by the Bavarian State Medical Association were obtained under reference numbers 13023 (main study) and 13031 (MRI ancillary study). Both approvals were recorded when the NAKO study was registered in the German Clinical Trials Register (DRKS). The corresponding DRKS registration number is DRKS00037328 (registration date: September 11th, 2025). An independent ethics advisory board has been established to provide oversight of NAKO throughout the entire study period. Furthermore, a NAKO Code of Ethics ( Ethikkodex ) was developed, and the study is continuously monitored by the ethics committees of the regional study centers (Peters et al., 2022). Written informed consent was obtained from all participants.
Consent for publication: Not applicable.
Competing interests: The authors declare no competing interests.
