Laaksonen, Mikael http://orcid.org/0009-0003-1879-0418
Rinne, Jaakko
Rahi, Melissa
Posti, Jussi P.
Laitio, Ruut
Kivelev, Juri
Saarenpää, Ilkka
Laukka, Dan
Frösen, Juhana
Ronkainen, Antti
Bendel, Stepani
Långsjö, Jaakko
Ala-Peijari, Marika
Saunavaara, Jani
Parkkola, Riitta
Nyman, Mikko
Martikainen, Ilkka K.
Dickens, Alex M.
Rinne, Juha
Valtonen, Mika
Saari, Teijo I.
Koivisto, Timo
Bendel, Paula
Roine, Timo
Saraste, Antti
Vahlberg, Tero
Tanttari, Juha
Laitio, Timo
Funding for this research was provided by:
Biotieteiden ja Ympäristön Tutkimuksen Toimikunta (333010)
State Research Funding of South-Western Finland
Suomen Anestesiologiyhdistys
Suomen Lääketieteen Säätiö
Article History
Received: 27 March 2023
Accepted: 5 June 2023
First Online: 19 June 2023
Declarations
:
: This trial has been approved by the National Committee on Medical Research Ethics TUKIJA (June 15, 2020; Dnro 67/06.00.01/2020) and by the Finnish Medicines Agency FIMEA (September 18, 2020; KLno. 60/ 2020) and registered in the European Union database C-TIS portal (June 22, 2022, no. 2022-500596-32-00). In addition, the Hospital District of Southwest Finland has approved this trial (October 25, 2021; 194/2021). The principal investigator (PI) is responsible for keeping TUKIJA and FIMEA informed of any SAEs and amendments as requested. All amendments will be submitted to TUKIJA and FIMEA via EU C-TIS portal. The PI should file all correspondence with the TUKIJA and FIMEA in the Investigator’s Study File.
: Model consent forms for both patient and next of kin, as well as all documentation given to the study subject and family member, have been attached as separate documents with this submission.
: AS received research grants from the Academy of Finland, Juselius Foundation, and the Finnish Foundation for Cardiovascular Research; consultancy fees from Astra Zeneca, Boehringer Ingelheim, and Pfizer; and speaker fees from Abbott, Astra Zeneca, Bayer, and Novartis unrelated to the current study.All other authors declare no competing interests.