Ruigómez, Ana
Plana, Estel
Gilsenan, Alicia
Fortuny, Joan
Cainzos-Achirica, Miguel
Flynn, Robert W. V.
MacDonald, Thomas M.
Garcia-Rodriguez, Luis
Ziemiecki, Ryan
Andrews, Elizabeth B.
Funding for this research was provided by:
Shire Pharmaceuticals GmbH, now part of the Takeda group of companies
Article History
Accepted: 11 January 2021
First Online: 19 February 2021
Declarations
:
: This study was funded by Shire Pharmaceuticals GmbH, now part of the Takeda group of companies.
: This study was performed under a research contract between RTI Health Solutions and Shire Pharmaceuticals GmbH, now part of the Takeda group of companies. The content of the publication was developed independently from the sponsor. Alicia Gilsenan, Joan Fortuny, Estel Plana, Miguel Cainzos-Achirica, Ryan Ziemiecki, and Elizabeth B. Andrews are or were salaried employees of RTI Health Solutions at the time the study was conducted. Miguel Cainzos-Achirica now works at Houston Methodist DeBakey Heart and Vascular Center and has participated in a research study funded by a non-conditioned research grant from Vifor. Ana Ruigómez and Luis-Alberto Garcia-Rodriguez work at the Spanish Centre for Pharmacoepidemiologic Research (CEIFE Madrid, Spain), which has received research funding from RTI Health Solutions. Luis-Alberto Garcia Rodriguez also received honoraria for serving on advisory boards for Bayer AG. Robert W.V. Flynn is an employee of the University of Dundee and has received research grants from Novartis and GlaxoSmithKline. Professor Thomas M. MacDonald is an employee of the University of Dundee who received financial support under the research contract between RTI Health Solutions and Shire Pharmaceuticals GmbH, now part of the Takeda group of companies, to carry out the study. Thomas M. MacDonald also works with MEMO Research at the University of Dundee and received or has received research funding from Novartis, Amgen, Ipsen, GRK Teijin, and Menarini and has received honoraria for educational lectures from Takeda. He has been the Principal Investigator on trials paid for by Novartis, Ipsen, Teijin, GlaxoSmithKline, and Menarini. In the last 3 years, he has been paid consulting fees by Novartis.
: All relevant authorities reviewed and approved the study on ethical grounds in the UK: the Independent Scientific Advisory Committee for CPRD GOLD; the Scientific Review Committee for THIN; and the East of Scotland Research Ethics Services and the Public Benefit and Privacy Panel for Health and Social Care for ISD, who allowed such access for regulatory purposes for the first time.
: Not applicable.
: Not applicable.
: For data obtained from the CPRD and THIN, data access is available and subject to a license agreement that contains terms and conditions of use set forth by UK Medicines and Healthcare Products Regulatory Agency. For data obtained from ISD, data access is available subject to the terms and conditions set forth by the NHS National Services Scotland.
: Not applicable.
: AR, AG, JF, and MC contributed to the conception and planning of the work, analysis and interpretation of the data, and drafting the manuscript. EP contributed to the analysis and interpretation of the data and drafting of the manuscript. RF, TM, LG, RZ, and EA contributed to the analysis and interpretation of the data and critical revision of the manuscript. All authors read and approved the final version.