1Hormone Hamburg, Hamburg, Germany
2Astellas Pharma Global Development, Northbrook, IL, USA
3Clinique de Recherche en Santé de la Femme, Quebec City, Canada
4Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden
5University of Valencia, Valencia, Spain
6University of Toronto, Toronto, ON, Canada
7Inselspital, Bern, Switzerland
8Astellas Pharma, Tokyo, Japan
9Astellas Pharma Europe, Addlestone, Surrey, UK
10University of Pavia, Pavia, Italy
11Research Center for Reproductive Medicine and Gynecological Endocrinology - Menopause Unit, Fondazione Policlinico IRCCS S Matteo, Pavia, Italy
Correspondence to: R E Nappi [email protected]
Accepted September 25, 2024
We thank the DAYLIGHT study investigators, staff, and all participants who took part in the study. Yien Liu, from Envision Pharma (Fairfield, CT) provided medical writing support, funded by the study sponsor.
Contributors: All authors contributed to the conception or design of the study; the acquisition, analysis, or interpretation of the data; drafting of the manuscript; or reviewing of the manuscript for important intellectual content. The authors also provided final approval of the version to be submitted and agree to be accountable for all aspects of the manuscript. KS is the guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
Funding: This study was funded by Astellas Pharma. All authors can confirm their independence from the funder, and all authors, external and internal, had full access to all the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest and declare: support from Astellas Pharma. KS has received payment or honorariums for lectures, presentations, speakers bureaus, manuscript writing, or educational events from aidhere, Astellas Pharma, Bayer/Jenapharm, Besins Healthcare, Exeltis, Fidia, Gedeon Richter Pharma, Novo Nordisk, Organon, Theramex, Viatris, and Laborarztpraxis Rhein-Main; participates on a data safety monitoring board or advisory board for Astellas, Bayer, Exeltis, Besins Healthcare, and Viatris; is President of the German Menopause Society organises and lectures at conferences for the society; lectures and participates in conferences for the professional association of gynaecologists in Germany; is honorary member for the German Society of Obstetrics and Gynecology and lectures, is president at conferences, and participates on committees for the society. XWang, XWu, and KM are employees of Astellas Pharma. CB has received research grants from Astellas, Incyte, and Mithra; consulting fees from Bayer Pharma, Astellas, and AbCellera; and honorariums for lectures from Pfizer, Lupin, and Orimed. ALH receives consulting fees from Astellas, Besins, and Exeltis; payments or honorariums for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Astellas, Besins, Gedeon Richter, and Bayer; support for attending meetings and/or travel from Astellas and Besins; participates on a data safety monitoring board or advisory board for Exeltis. AC has received payment or honorariums for educational events from Theramex and Astellas; support for attending meetings and travel from Astellas; participates on advisory boards for Astellas and Theramex. MSCM sits on advisory boards for and has received consulting fees and honorariums from Amgen, Aspen, Astellas, BioSyent, Bayer, CCRN, Duchesnay, Eisai, GSK, Idorsia, Merck, Mithra, Novo Nordisk, Organon, Pfizer, Sandoz, and Searchlight; receives support for attending meetings and/or travel from Astellas and The Menopause Society; has a leadership or fiduciary role in other board, society, committee, or advocacy group, paid or unpaid, for the International Menopause Society and Terry Fox Research Institute. PS has received grants or contracts from the University of Bern and Swiss National Foundation; consulting fees from Astellas and Theramex; payment or honorariums for lectures, presentations, speakers bureaus, manuscript writing, or educational events for Astellas, Theramex, and Besins Healthcare; leadership or fiduciary role in other board, society, committee, or advocacy group, paid or unpaid for the European Menopause and Andropause Society, Deutsche Menopause Gesellschaft, and Swiss Society for Anti Aging Medicine and Prevention. LS was an employee of Astellas Pharma at the time of development. REN receives grants/contracts from Fidia; consulting fees from Astellas, Bayer Pharma, Besins Healthcare, Fidia, and Theramex; payment or honorariums for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Abbott, Astellas, Exeltis, Fidia, Gedeon Richter, Merck, Novo Nordisk, Shionogi, Theramex, and Viatris; payment for expert testimony from Vichy Laboratories; and is president elect of the International Menopause Society.
Transparency: The manuscript's guarantor (KS) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Dissemination to participants and related patient and public communities: The clinical study report synopsis and plain language summary have been posted on the Astellas clinical trials website (https://www.clinicaltrials.astellas.com). In addition, the plain language summary has been posted on the multi-sponsor website, trial results summaries (https://www.trialsummaries.com/Home/LandingPage). DAYLIGHT findings have been submitted as part of the evidence base for health technology assessment processes, which include critical participation and input from individuals with vasomotor symptoms associated with menopause.
Provenance and peer review: Not commissioned; externally peer reviewed.
Ethical approval This study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice, and International Council for Harmonisation guidelines. An independent ethics committee or institutional review board reviewed ethical, scientific, and medical appropriateness of the study before data collection at each site: Canada: Advarra IRB (Ontario, Canada); Netherlands: Medical Research Ethics Committees United (MEC-U), St Antonius Ziekenhuis (Nieuwegein, Netherlands); Belgium: EC of UZ Gent, Medical Ethics Committee, University Hospital Gent (Gent, Belgium); France: Comité de Protection des Personnes Sud-Ouest et Outre-Mer 1, Regional Health Agency (Toulouse, France); Spain: EC Gregorio Marañón, Secretaría Técnica CEIm, Fundación para la Investigación Biomédica Hospital Gregorio Marañón, Pabellón de Gobierno (Madrid, Spain); Finland: Ethics Committee of Hospital District of Northern Savo, Kuopio University Hospital (Kuopio, Finland); Hungary: Medical Research Council (Budapest, Hungary); Italy: CEC, Comitato Etico Referente Area di Pavia Fondazione IRCCS Policlinico “San Matteo” (Pavia, Italy); Czech Republic: Etická komise pro multicentrická klinická hodnocení Fakultní nemocnice, Královské Vinohrady (Prague, Czech Republic); UK: London - Westminster Research Ethics Committee (Nottingham, UK); Denmark: Den Videnskabsetiske Komité for Region Nordjylland Regionssekretariatet (Aalborg, Denmark); Sweden: Etikprövningsmyndigheten (Uppsala, Sweden); Norway: REK sør-øst (Oslo, Norway); Poland: Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Lublinie (Lublin, Poland); Germany: Ethikkommission der Fakultät für Medizin der Technischen Universität (Munich, Germany); Turkey: Ankara University Tip Fakultesi, Clinical Trial Ethics Committee (Ankara, Turkey). Written informed consent was obtained from all participants before any study related procedures.
Data availability statement Researchers may request access to anonymised participant level data, trial level data, and protocols from Astellas sponsored clinical trials at www.clinicalstudydatarequest.com. For the Astellas criteria on data sharing, see https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Astellas.aspx.
