Document is current

Article History

Received: 6 March 2023

Accepted: 12 May 2023

First Online: 19 May 2023

Declarations

:

: This study will be conducted according to the principles of the Declaration of Helsinki (Version: 19th October 2013, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013) and according to Good Clinical Practice (GCP) guidelines. Moreover, the study will be conducted in accordance with the Medical Research Involving Human Subjects Act (WMO) and the Dutch General Data Protection Regulation (AVG). The study protocol was approved by the ethics committee of Maastricht University Medical Center + and Maastricht University (azM/UM) (identifier: NL73003.068.20 / METC 20–056). Participation of each study site has also been approved locally by the boards of the participating centres. Written informed consent will be requested from all study participants after the nature of the study and possible risks have been explained by the principal or coordinating investigator.The sponsor/investigator has a liability insurance which is in accordance with article 7 of the WMO. The sponsor (also) has an insurance which is in accordance with the legal requirements in the Netherlands (Article 7 WMO). This insurance provides cover for damage to research subjects through injury or death caused by the study. The insurance applies to the damage that becomes apparent during the study or within 4 years after the end of the study.

: Not applicable.

: The authors declare no competing interests.