Scheres, Lotte M. J. http://orcid.org/0000-0002-0262-0540
van den Biggelaar, Frank J. H. M.
Winkens, Bjorn
Kujovic-Aleksov, Stefani
Müskens, Rogier P. H. M.
de Waard, Peter W. T.
de Crom, Ronald M. P. C.
Ernest, Paul J. G.
Pijl, Benjamin J.
Ramdas, Wishal D.
van Rijn, Laurentius J.
Tan, Annelie
Dirksen, Carmen D.
Beckers, Henny J. M.
Article History
Received: 19 October 2022
Accepted: 10 December 2022
First Online: 31 January 2023
Declarations
:
: This study will be conducted in accordance with the Declaration of Helsinki as well as the Netherlands Medical Research Involving Human Subjects Act (WMO), and was approved as a primary review by the ethics committee of Maastricht University Medical Center+ and Maastricht University (azM/UM) (identifier: NL68964.068.19/ METC 19-027), which suffices for all participating centres under the Dutch law. Participation of each study site has been locally approved by the boards of all participating centres. Before randomisation, written informed consent will be requested from all study participants after the nature of the study and possible risks have been explained. Trial registration is available in the ClinicalTrials.gov database with registration number: NCT03931564.
: Not applicable.
: RdC and HB report consulting and lecturing for Santen. HB reports a research sponsorship from InnFocus Inc., a Santen company. Activities are unrelated to the current work and Santen has no influence on the design and execution of the study. All other authors declare that they have no competing interests.