Smits, Elisabeth http://orcid.org/0000-0003-1882-4748
Andreotti, Felicita
Houben, Eline
Crijns, Harry J. G. M. http://orcid.org/0000-0003-1073-5337
Haas, Sylvia
Spentzouris, George
Schink, Tania http://orcid.org/0000-0002-0224-1866
Gini, Rosa
Bartolini, Claudia http://orcid.org/0000-0001-8630-4598
Penning-van Beest, Fernie http://orcid.org/0000-0002-1906-9724
Herings, Ron
Funding for this research was provided by:
daiichi sankyo europe
Article History
Accepted: 24 November 2021
First Online: 6 January 2022
Declarations
:
: This study was funded by Daiichi Sankyo Europe GmbH. The authors had complete autonomy in the process of establishing the protocol, carrying out the analyses, and interpreting the results and the authors retained the full right to publish the results without limitation.
: Elisabeth Smits, Eline Houben, Fernie Penning-van Beest and Ron Herings are employees of the PHARMO Institute for Drug Outcomes Research. This independent research institute performs financially supported studies for government and related healthcare authorities and pharmaceutical companies. Felicita Andreotti, Harry Crijns and Sylvia Haas report personal fees/advisory board fees from Daiichi Sankyo Europe during the conduct of the study. Tania Schink is working at an independent non-profit research institute, the Leibniz Institute for Prevention Research and Epidemiology, BIPS. Unrelated to this study, BIPS occasionally conducts studies financed by the pharmaceutical industry. Almost exclusively, these are post-authorisation safety studies requested by health authorities. The design and conduct of these studies as well as the interpretation and publication are not influenced by the pharmaceutical industry.
: This observational study analysed de-identified data from the PHARMO Database Network; therefore, the study was exempt from ethical review and informed consent was not required.
: Not applicable.
: Not applicable.
: The data in this study are available from the PHARMO Database Network. As restrictions apply to the availability of these data, they are not publicly available. Data can be made available from the PHARMO Database Network upon request.
: Not applicable.
: All authors contributed to the study conception and design. Material preparation and analysis were performed by ES, EH, TS, RG and CB. The first draft of the manuscript was written by ES, FA and EH and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.