Document is current

Article History

Received: 25 July 2024

Accepted: 2 September 2024

First Online: 20 September 2024

Declarations

:

: The trial is conducted according to the principles of the Declaration of Helsinki, the Medical Research Involving Human Subjects Act (WMO), and the Medical Treatment Agreement Act (WGBO). The data will be collected and processed in accordance with the General Data Protection Regulation (EU) 2016/679 and in compliance with national requirements on data protection, Dutch Personal Data Protection Act (WBP). The current ethics approval is granted by the medical research Ethics Committees United (MEC-U) as of August 11, 2022, by Clinical Trials Information System (CTIS) [reference EU CT-number: 2022–500745-24–00]. The trial has been registered with ClinicalTrials.gov [NCT05513365; date of registration August 24, 2022]. Oral and written informed consent will be obtained from all subjects prior to any study related procedures. Informed consent will be written, dated, and signed by the treating physician, and by the subject or, when the subject is not able to give informed consent, their legally designated representative. Subjects also provide additional consent for the use of data and biological specimens collected as part of this trial for the use in ancillary studies to SGC.

: Not applicable.

: JW, GV, GL, AvEvG, CD, MJ: No competing interests.NvE: Research grants (institution): Astellas and Ipsen.JS: Speakers honorarium: ‘Astellas, Bayer.’CvH: Advisory (institution): Bayer, Bristol-Myers Squibb, Ipsen, MSD, Regeneron,. Research grant (institution): Astra Zeneca, Bristol-Myers Squibb, MSD, Merck, Ipsen, Novartis, and Sanofi.