Bernardi, Martin H. http://orcid.org/0000-0002-8297-898X
Bettex, Dominique
Buiteman–Kruizinga, Laura A.
de Bie, Ashley
Hoffmann, Matthias
de Kleijn, Janine
Serafini, Simon Corrado
Molenaar, Manon A.
Paulus, Frederique
Peršec, Jasminka
Neto, Ary Serpa
Schuepbach, Reto
Severgnini, Paolo
Šribar, Andrej
Schultz, Marcus J.
Tschernko, Edda
,
Article History
Received: 26 March 2024
Accepted: 25 June 2024
First Online: 3 July 2024
Declarations
:
: The Ethics Committee of the Medical University of Vienna approved the protocol POSITiVE II vers 1.1 (EK Nr. 1696/2023) on September 29, 2023. Written, informed consent to participate will be obtained from all participants.Recruitment at other centers is started as soon as local ethical approval is obtained for the other centers. The Ethics Committee of the Medical University of Vienna is notified on all amendments. Local investigators are reported on and trained in important protocol modifications, if this happens.The study will be conducted according to the Good Clinical Practice guidelines and comply with the principles of the Declaration of Helsinki, national and international regulatory requirements and general data protection regulations. The study will be registered in a public registry and the study protocol with its statistical analysis plan will be prepublished.
: Not applicable.
: Laura Buiteman–Kruizinga received fees from Hamilton Medical AG for lecturing. Prof Reto Schuepbach declares ongoing studies with Hamilton medical and an education sponsorship. Prof Marcus J. Schultz was Team Leader Medical Research at Hamilton Medical AG, Bonaduz, Switzerland, from January 2022 till January 2023, and receives grants from Zorgonderzoek Medische wetenschappen (ZonMw) in the Netherlands. The other authors declare that they have no competing interests.