Document is current

Article History

Accepted: 29 September 2024

First Online: 7 November 2024

Declarations

:

: This work was funded by Bayer AG, Wuppertal, Germany. Editorial support, including writing, fact checking, referencing, figure preparation, formatting, proofreading and submission was provided by Moamen Hammad, PhD, Patricia Badia Folgado, MSc and Melissa Ward, BA, all of Scion (a division of Prime, London, UK) supported by Bayer AG, Wuppertal, Germany according to Good Publication Practice guidelines (<u>Link</u>).

: Christine Brase and Friederike Kanefendt are employees of Bayer AG and own shares or share options in the company. Sebastian Schmitz was an employee of Bayer AG at the time of the manuscript development and may own shares or share options in the company. Katharina Sommer is an employee of ClinStat GmbH and reports consulting or advisory roles of her CRO with Bayer AG. Atef Halabi has nothing to disclose.

: The conduct of the clinical studies met all local legal and regulatory requirements. The studies were conducted in accordance with the Declaration of Helsinki and the International Council for Harmonisation guideline E6: Good Clinical Practice. The protocols and other related materials were reviewed and approved by the relevant institutional boards for each study: IntegReview Institutional Review Board, Austin, Texas and QPS Bio-Kinetic, Biokinetic Clinical Applications institutional review board, Springfield, Missouri for study 1 and Ethik-Kommission der Arztekammer Schleswig-Holstein, Kiel, Germany for studies 2 and 3.

: Informed consent was obtained from all individual participants included in the studies.

: Not applicable.

: Availability of the data underlying this publication will be determined later according to Bayer’s commitment to the EFPIA/PhRMA principles for responsible clinical trial data sharing. This pertains to scope, time point, and process of data access. As such, Bayer commits to sharing, upon request from qualified scientific and medical researchers, participant-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in participants for medicines and indications approved in the United States (US) and European Union (EU) as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 1, 2014. Interested researchers can use to request access to anonymised participant-level data and supporting documents from clinical studies to conduct further research that can help advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the study sponsor’s section of the portal. Data access will be granted to anonymised participant-level data, protocols, and clinical study reports after approval by an independent scientific review panel. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that participant privacy is safeguarded.

: Not applicable.

: Christine Brase and Friederike Kanefendt (all studies) and Sebastian Schmitz (studies 1 and 2) and Katharina Sommer (study 3) made substantial contributions to the conception or design of the work. Christine Brase and Friederike Kanefendt (all studies), and Sebastian Schmitz (studies 1 and 2), Katharina Sommer (study 3) and Atef Halabi (studies 2 and 3) made substantial contributions to the acquisition of the data. Christine Brase and Friederike Kanefendt (all studies) and Sebastian Schmitz (studies 1 and 2) and Katharina Sommer (study 3) made substantial contributions to the analysis of the data. Christine Brase and Friederike Kanefendt (all studies) and Sebastian Schmitz (studies 1 and 2) and Katharina Sommer (study 3) made substantial contributions to the interpretation of the results. All authors drafted the work or revised it critically for important intellectual content, approved the version to be published and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.