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Authors
Melado, Laura https://orcid.org/0000-0001-5450-4130
Kumar, Ajay
Kalra, Bhanu
Kalafat, Erkan
Lawrenz, Barbara
Fatemi, Human
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Article History
Received: 20 June 2025
Accepted: 14 August 2025
First Online: 27 August 2025
Declarations
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: The authors declare no competing interests.
: Ethical approval was obtained from the institutional Research Ethics Committee (REFA033c), and the study was registered at Clinicaltrials.gov (NCT03826888). All participants provided written informed consent prior to enrollment.
: • The subjects in this trial have not concomitantly been involved in other randomized trials. • Data regarding any of the subjects in the study has not been previously published. • Data will be made available to the journal’s editors for review or query upon request.
