Smit, Eva R.
Muñoz Sandoval, Diana
Kreft, Iris C.
van der Meer, Pieter F.
van der Zwaan, Carmen
Voorberg, Jan
Ypma, Paula F.
Hoogendijk, Arie J.
Kerkhoffs, Jean-Louis
van den Biggelaar, Maartje
Article History
Received: 22 April 2024
Accepted: 30 August 2024
First Online: 9 September 2024
Declarations
:
: All participants gave written informed consent before the randomization procedure or any other study-related procedure. The protocol and methods used was published previously and the study was registered at the Netherlands National Trial Registry under number NTR2106 as well as at clinicaltrials.gov under number NCT02783313. Briefly, the protocol was approved centrally and by site institutional review boards and according to the criteria outlined in the Declaration of Helsinki and Good Clinical Practice guidelines.
: Informed consent was obtained from patient(s).
: None of the authors have competing interests in relation to this publication.