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Article History

Received: 23 March 2023

Accepted: 26 October 2023

First Online: 4 November 2023

Declarations

:

: The study was approved by the Finnish Institute for Health and Welfare (THL/6957/14.02.00/2020). According to Finnish legislation (Act on the Secondary Use of Health and Social Data (552/2019) by the Ministry of Social Affairs and Health), the approval of an ethical committee or informed consent is not required for non-interventional, observational retrospective registry studies. The study was conducted in accordance with the Declaration of Helsinki, Good Pharmacoepidemiology Practice (GPP), and the General Data Protection Regulation (GDPR). RCT data were not collected for the investigations presented herein, but as part of the original trial. The original RCT collection was based on informed consent from patients participating in a clinical trial (the PACIFIC-AF phase II clinical trial; ClinicalTrials.gov Identifier: NCT04218266). Importing of the RCT data to the same analysis environment with the RWD data was approved by the Finnish Institute for Health and Welfare (THL/6571/14.06.00/2021).

: Not applicable.

: JM is employed by MedEngine Oy. MA and TM are employed by Veil.ai Oy. LP, KL, PTN, IK, SS, SK, JV, KA, JVL are employed by Bayer.