Document is current

Article History

Accepted: 8 April 2021

First Online: 4 June 2021

Declarations

:

: This work was supported by Bayer AG, Berlin, Germany and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

: Hauke Ruehs, Dagmar Klein, Matthias Frei, Corina Becker, Lothar Roessig, Dirk Garmann, and Michaela Meyer are employees and potential stockholders of Bayer AG and may own stock in the company. Joachim Grevel and Rupert Austin are employees of BAST Inc. Limited and paid consultants for Bayer Healthcare Pharmaceuticals. Burkert Pieske served as the Study Chair on the Executive Committee of SOCRATES and received advisory honoraria and speakers’ fees from Bayer Healthcare and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

: The SOCRATES-REDUCED protocol was approved by the ethics committee or institutional review board of each study site. The study was conducted in accordance with the Declaration of Helsinki and adhered to the International Conference of Harmonization good clinical practice guidelines.

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

: Not applicable.

: Availability of the data underlying this publication will be determined according to Bayer’s commitment to the EFPIA/PhRMA “Principles for responsible clinical trial data sharing”. This pertains to scope, timepoint, and process of data access. As such, Bayer commits to sharing upon request from qualified scientific and medical researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the USA and European Union as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the European Union and US regulatory agencies on or after 1 January, 2014. Interested researchers can use to request access to anonymized patient-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 sponsors section of the portal. Data access will be granted to anonymized patient-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 patient privacy is safeguarded.

: Not applicable.

: All authors were involved in at least one of the following: conception, design of work or acquisition, analysis, interpretation of data, and drafting the manuscript and/or revising/reviewing the manuscript for important intellectual content.