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Article History

Received: 8 May 2018

Accepted: 7 May 2019

First Online: 22 May 2019

Ethics approval and consent to participate

: The study was conducted by following the Code of Conduct of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and registered into the ENCePP e-register of studies (EUPAS8205). Study protocol is available online via ENCePP: ExternalRef removed (accessed 3 Nov 2017). The protocol was reviewed and approved by the Ethical Review Board of Hospital District of Helsinki and Uusimaa, Finland (139/13/03/00/15). This was a non-interventional retrospective register-based study with no contact with the patients. Requirement for patient consent was waived by ethics committee and applicable legislation.Data permits were applied as follows: data for diagnoses, interventions, hospitalization periods and institutionalization (other than hospitalization) periods from the National Institute for Health and Welfare (THL/550/5.05.00/2015); data for reimbursed drug purchases, special reimbursement statuses and information about place of domicile from the Social Insurance Institution (Kela 41/522/2015); and data for time and causes of death from Statistics Finland (TK53–617-15).

: Not applicable.

: Ville Kytö, Eeva Reissell and Juhani Airaksinen have received fees from pharmaceutical industry for consultancy regarding educational or advisory activities. Tuire Prami and Houssem Khanfir are employees of EPID Research, a contract research organization. EPID Research performs commissioned pharmacoepidemiological studies, and thus its employees have been and currently are working in collaboration with several pharmaceutical companies.Pål Hasvold is an employee of the sponsor, AstraZeneca Nordic Baltic.

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