,
Dorland, Galina https://orcid.org/0009-0002-2251-0821
Vermeulen, Tom D.
Hollmann, Markus W.
Schultz, Marcus J.
Hol, Liselotte
Nijbroek, Sunny G. L. H.
Breel–Tebbutt, Jenni S.
Neto, Ary Serpa
Mazzinari, Guido
Gasteiger, Lukas
Ball, Lorenzo
Pelosi, Paolo
Almac, Emre
Navarro, Maria P. Argente
Battaglini, Denise
Besselink, Marc G.
Bokkerink, Patty E. M. M.
van den Broek, Janneke
Buise, Marc P.
Broens, Suzanne
Davidson, Zoë
Cambronero, Oscar Díaz
Dejaco, Hannes
Ensink-Tjaberings, Petra Y.
Florax, Anna A.
de Abreu, Marcelo Gama
Godfried, Marc B.
Harmon, Matthew B. A.
Helmerhorst, Hendrik J. F.
Huhn, Ragnar
Huhle, Robert
Jetten, Wesley D.
de Jong, Merijn
Koopman, Joseph S. H. A.
Koster, Stephanie C. E.
de Korte-de Boer, Dianne J.
Kuiper, Geert-Jan A. J. M.
Trip, Charlotte N. Laman
Morariu, Aurora M.
Nass, Stefan A.
Oei, Gezina T. M. L.
Pap−Brugmans, Alice C.
Paulus, Frederique
Potters, Jan-Willem
Rad, Mandana
Robba, Chiara
Sarton, Elise Y.
Servaas, Sjoerd
Smit, Kirsten F.
Stamkot, André
Thiel, Bram
Struys, Michel M. R. F.
van de Wint, Thijs C.
Wittenstein, Jakob
Zeillemaker-Hoekstra, Miriam
van der Zwan, Tim
Hemmes, Sabrine N. T.
van Meenen, David M. P.
Staier, Nikolai
Mörtl, Maximilian
Funding for this research was provided by:
ZonMw
Article History
Received: 26 November 2023
Accepted: 17 September 2024
First Online: 26 October 2024
Declarations
:
: Central ethical approval has been obtained from the METC of the Amsterdam UMC (reference number: 2023.0439—NL82971.018.23) on 26 September 2023. Recruiting will not start at other centers in the trial until local ethical approval has been obtained. All amendments will be notified to the METC of the Amsterdam UMC, and significant protocol modifications will be reported to the local investigators. Before inclusion in this study, informed consent will be obtained from each patient. Participants will be asked if they agree that their data will be used should they choose to withdraw from the trial. The GENERATOR trial does not involve collecting biological specimens for storage. The sponsor has an insurance, which complies with the legal requirements in the Netherlands. 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 that they have no competing interests.