Burke, Colin http://orcid.org/0009-0001-4671-7600
Crossan, Catriona
Tyas, Emma http://orcid.org/0009-0002-6984-1425
Hemstock, Matthew http://orcid.org/0000-0002-8585-0586
Lee, Dawn http://orcid.org/0000-0003-4027-8456
Bowditch, Sally http://orcid.org/0000-0002-6918-2936
Funding for this research was provided by:
Jazz Pharmaceuticals, Inc
Article History
Accepted: 24 January 2024
First Online: 5 March 2024
Declarations
:
: This study and open access fee were funded by GW Pharmaceuticals, now a part of Jazz Pharmaceuticals, Inc. Authors Colin Burke, Catriona Crossan, Emma Tyas, Matthew Hemstock, and Dawn Lee were employed by Lumanity during the study, and their time for development and completion of the study was supported by Jazz Pharmaceuticals, Inc. Author Sally Bowditch, employed by Jazz Pharmaceuticals, Inc., had the following involvement with the study: study design, interpretation of data, writing of the article, and decision to submit for publication.
: All authors met the ICMJE authorship criteria and had full access to the relevant data. Neither honoraria nor payments were made for authorship. Colin Burke and Emma Tyas are employees of Lumanity, Inc.; Catriona Crossan, Matthew Hemstock, and Dawn Lee were employees of Lumanity, Inc., when the study was conducted and are currently employed by Putnam, Source Health Economics, and the University of Exeter, respectively. Sally Bowditch is an employee of Jazz Pharmaceuticals, Inc., and holds stock/stock options in Jazz Pharmaceuticals, Inc.
: All data generated or analyzed during this study are included in this published article (and its online resource files) with the exception of commercially confidential data.
: The present study was based on clinical trial data GWPCARE6 (NCT02544763). The trial was approved by an institutional review board or ethics committee at each participating site (Australia: Hunter New England Research Office; Netherlands: Medical Ethics Review Committee Erasmus MC; Poland: Komisja Bioetyczna przy Instytucie; Spain: Centro Medico Teknon; UK: North East—Newcastle & North Tyneside 2 Research Ethics Committee; USA: Copernicus Group Independent Review Board and Western Institutional Review Board) and was conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonisation Tripartite Guideline on Good Clinical Practice.
: All patients or their caregivers provided written informed consent, and patients developmentally mature enough to understand the trial provided assent.
: All patients or their caregivers provided written informed consent, and patients developmentally mature enough to understand the trial provided assent.
: The cost-effectiveness model used in the study is available from the corresponding author on reasonable request.
: All authors met the ICMJE authorship criteria and had full access to relevant data. CB, CC, DL, and SB contributed to the conception and design of this study. CB, CC, and DL contributed to the acquisition and analysis, and all authors contributed to the analysis and interpretation of data. CB, CC, and SB drafted the manuscript, and all authors were involved in critical review of the manuscript for important intellectual content. All authors read and gave their final approval of the version to be published and agree to be accountable for all aspects of the work.