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Article History

Accepted: 22 March 2022

First Online: 25 May 2022

Declarations

:

: This work was funded by Bayer AG, Wuppertal, Germany. Editorial support, including fact checking, referencing, figure preparation, formatting, proofreading, and submission was provided by Evangelia Giannakouri, PhD, and Ian Norton, PhD, of Scion, London, UK, supported by Bayer AG, Wuppertal, Germany, according to Good Publication Practice guidelines.

: RH and JN are employees of Bayer AG. SL is an employee of Chrestos Concept GmbH & Co. KG, which received funding for this analysis from Bayer AG. In addition, RH and JN have stock in Bayer AG, but are not paid in stock or stock options.

: All procedures in this study were in accordance with the 1964 Declaration of Helsinki (and its amendments). This article does not contain any studies with animals performed by any of the authors. All study protocols were reviewed and approved by the ethics committee of the respective medical council (Düsseldorf [studies 1 and 3] and Berlin [study 2], Germany) and by the Bundesinstitut für Arzneimittel und Medizinprodukte (The Federal Institute for Drugs and Medical Devices), Bonn, Germany.

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

: 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 anonymized 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 anonymized 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.

: RH, JN, and SL participated in the study concept and design and were involved in the acquisition, analysis, and interpretation of the respective data. All authors participated in preparing and approving the manuscript.