Document is current

Article History

Received: 16 November 2020

Accepted: 3 December 2021

First Online: 18 January 2022

Declarations

:

: The original study protocol (version 1.0) and the protocol with the latest amendments (version 1.3) were approved by the medical ethical committee (registration number 2018_054) and the board of directors of the Academic Medical Center in Amsterdam on 24 May 2018 and 11 March 2019 respectively. The study is registered at the Netherlands Trial Register with the number NL6584/NTR6758 and at with the number NCT03582293. This trial will be conducted in agreement with the principles of the Declaration of Helsinki. All participants will be informed about the purpose of the trial, the risks and the potential benefits. If the participant is not mentally competent, a legal representative will be informed as well. Written informed consent will be obtained by the local study coordinator from each participant or legal representative before the start of baseline measurements and study treatment.

: All study participants sign an informed consent form by which they give consent for publication of the pseudonymously collected study data.

: The authors declare that they have no competing interests.