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Article History

Received: 29 May 2019

Accepted: 26 September 2019

First Online: 26 November 2019

Compliance with ethical standards

: This was an observational register study with no contact or intervention directed to the patients. The study was conducted by following the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) as well as the guidelines for good pharmacoepidemiology practice (GPP) [, ]. The protocol was reviewed and approved by the Ethical Review Board of Hospital District of Helsinki and Uusimaa, Finland (131/13/03/00/14), and the study was registered into the EUPAS e-register of studies (EUPAS6161). Data permits were applied from National Institute for Health and Welfare (THL/522/5.05.00/2014), Social Insurance Institution (Kela 21/522/2014), and Statistics Finland (TK-53-532-14). The identification numbers of the patients were encrypted by these authorities before data delivery to the researchers.

: T. Prami was, and H. Khanfir is an employee of EPID Research that is a contract research organization. EPID Research performs commissioned pharmacoepidemiological studies and thus, its employees have been and are currently working in collaboration with several pharmaceutical companies. Since January 2018, T. Prami has been working for the Finnish Medicines Agency Fimea. P. Hasvold is an employee of the sponsor, AstraZeneca Nordic Baltic. E. Reissell and J. Airaksinen declare they have no conflicts of interest. V. Kytö: payment for lectures: Bayer, Boehringer-Ingelheim. Consulting fee: AstraZeneca.