Aarts, Lonneke A. M. https://orcid.org/0009-0008-0201-2327
van Geffen, Geert-Jan https://orcid.org/0000-0002-9305-124X
Smedema, Eva A. L. https://orcid.org/0009-0004-5315-5134
Smits, Rosanne M. https://orcid.org/0000-0003-2682-2654
Funding for this research was provided by:
National Health Care Institute (2017045964)
Article History
Received: 17 March 2023
Revised: 12 May 2023
Accepted: 22 May 2023
First Online: 17 June 2023
Declarations
:
: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the medical ethical committee CMO region Arnhem-Nijmegen (May 24, 2019/N0 2019-5488).
: Informed consent was obtained from all individual participants included in the study
: The authors affirm that human research participants provided informed consent for publication
: The authors have no relevant financial or non-financial interests to disclose.
: Subject, code and patient identification were saved in an identification log. A key file with password for the identifying personal data, linked to the study code, was saved on a separate file and was only accessible for the researchers. On the Case Report Form and in the database (Castor EDC) only coded data was used, no personal identification data. Data was saved for 15 years.