Heaf, James
Heiro, Maija
Petersons, Aivars
Vernere, Baiba
Povlsen, Johan V.
Sørensen, Anette Bagger
Clyne, Naomi
Bumblyte, Inga
Zilinskiene, Alanta
Randers, Else
Løkkegaard, Niels
Rosenberg, Mai
Kjellevold, Stig
Kampmann, Jan Dominik
Rogland, Björn
Lagreid, Inger
Heimburger, Olof
Qureshi, Abdul Rashid
Lindholm, Bengt
Funding for this research was provided by:
Baxter Healthcare Corporation (05253284, 05253284, 05253284, 05253284, 05253284, 05253284, 05253284, 05253284, 05253284, 05253284, 05253284, 05253284, 05253284, 05253284, 05253284, 05253284, 05253284, 05253284, 05253284)
Article History
Received: 25 March 2021
Accepted: 8 June 2022
First Online: 27 June 2022
Declarations
:
: All methods were carried out in accordance with relevant guidelines and regulations. The study protocol was approved by the ethical review boards in centers located in countries where according to the country´s regulations this was required. The study was approved by the Swedish Ethical Review Authority (Ref 2017/7), while in Denmark, due to the observational non-interventional design of the study using anonymized patient data, the study protocol was not considered to be eligible for ethical review. Informed consent—either written or verbal depending on the regulations in the different countries—was obtained from participants in all centers including those in Denmark, with the exception of Lithuania, where the need of informed consent was waived by the ethics board (Kaunas Regional Biomedical Research Ethics Committee; P2-BE-2–9/2014). The study is registered with Clinical Trials.gov, identifier NCT02488200. The Swedish approval was valid for all EU countries.
: Not applicable.
: Bengt Lindholm is employed by Baxter Healthcare at Baxter Novum, Karolinska Institutet. None of the other authors declare any conflicts of interest.