Ersbøll, Annette Kjær http://orcid.org/0000-0002-9407-3387
Sengupta, Kaushik
Pukkala, Eero
Bolin, Kristian
Aas, Eline
Emneus, Martha
Ramey, Dena Rosen
Brady, Joanne E.
Mines, Daniel
Aasbjerg, Kristian
Vestergaard, Christian
Gislason, Gunnar
Born, Alfred Peter
Kjærulff, Thora Majlund
Funding for this research was provided by:
Merck Sharp and Dohme
Article History
Accepted: 30 July 2021
First Online: 5 October 2021
Declarations
:
: The paper is based on data originating from a PASS that the European Medicines Agency requested from Merck & Co., Inc., Kenilworth, NJ, USA. Merck & Co., Inc., Kenilworth, NJ, USA contracted Applied Economics and Health Research (ApHER), an independent research institute, to conduct the study based on this regulatory request. This study was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
: AKE, KS, EP, EA, KA, GG, APB, and TMK declare no conflict of interest. ME serves as the main person responsible for the study as a partner of ApHER and has been involved in observational registry-based studies performed on a consultative basis for Merck Sharp & Dohme Corp. DRR, JEB, and DM were employees at Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, while the study was conducted. KB is responsible for the study in Sweden as a consultant for ApHER and has been involved in observational registry-based studies performed on a consultative basis for Merck Sharp & Dohme Corp. CV has received an unrestricted grant from Novartis, served in advisory boards, and received honoraria as lecturer from Novartis.
: According to the law in Denmark, Finland, Norway, and Sweden, registry-based studies can be performed without consent from the subjects if the purpose is performing statistical and scientific studies of significant public health concerns. The study was approved by the relevant national data agencies required by the four countries.
: The datasets generated and analyzed during the current study are not available. The researchers have access to data at servers at Statistics Denmark. According to the regulations at Statistics Denmark, it is not allowed to extract data from the servers at Statistics Denmark. Therefore, data are not available.
: Not applicable.
: Not applicable.
: Not applicable.
: AKE, EP, KB, ME, DRR, JEB, DM, and THK conceived the conception or design of this study. AKE, KS, and TMK conducted the statistical analyses. All authors contributed to the interpretation of the results. AKE and TMK drafted the manuscript. All authors commented on the manuscript and approved the final version of the manuscript.