Lloyd, Andrew http://orcid.org/0000-0002-7597-6556
Aggio, Daniel
Dixon, Caleb
Law, Ernest H.
Price, Thomas
Funding for this research was provided by:
Pfizer
Article History
Accepted: 28 May 2024
First Online: 6 July 2024
Declarations
:
: This study was supported by Pfizer Inc. Acaster Lloyd Consulting Ltd. retained complete control over the statistical analysis of the data and the initial draft of the paper.
: T.P. (Pfizer Ltd.) and E.H.L. (Pfizer Inc.) are employees of and hold stock or stock options in Pfizer. E.H.L. is a member of the EuroQol group, which is responsible for licensing the EQ-5D. D.A. and C.D. are employees of Acaster Lloyd Consulting Ltd. A.L. is an employee and shareholder of Acaster Lloyd Consulting Ltd and a board member of the EuroQol group. Acaster Lloyd Consulting Ltd were commissioned by Pfizer Inc, the study sponsor, to conduct the study.
: Upon request and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See for more information.
: Code for data cleaning and analysis in support of the analyses in the manuscript is available upon reasonable request.
: This study is a post hoc analysis of ALLEGRO phase 2b–3 clinical trial data. This was a randomised, double-blind, multicentre, phase 2–3 trial done at 118 hospitals and clinics in Argentina, Australia, Canada, Chile, China, Colombia, Czech Republic, Germany, Hungary, Japan, Korea, Mexico, Poland, Russia, Spain, Taiwan, the UK and the USA. This protocol was approved by the institutional review boards or ethics committees of the participating institutions. The study was conducted in accordance with the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences 2002), ICH Guideline for Good Clinical Practice and the Declaration of Helsinki. Written informed consent to participate was obtained from each patient. Written informed consent to publish the findings was also obtained from each patient.
: Concept and design: A.L., D.A., E.H.L., T.P. Acquisition of data: E.H.L, T.P. Analysis and interpretation: A.L., D.A., C.D., E.H.L., T.P. Drafting the manuscript: A.L., D.A., C.D. Critical review of the paper: A.L., D.A., E.H.L., T.P.