Ruehs, Hauke http://orcid.org/0000-0001-8543-7831
Solms, Alexander http://orcid.org/0000-0002-0945-2543
Frei, Matthias
Becker, Corina http://orcid.org/0000-0003-4715-6726
Trujillo, Maria E. http://orcid.org/0000-0002-9358-5532
Garmann, Dirk
Meyer, Michaela http://orcid.org/0000-0002-7245-9406
Funding for this research was provided by:
Bayer AG, Berlin, Germany
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA
Article History
Accepted: 25 June 2023
First Online: 6 September 2023
Declarations
:
: Hauke Ruehs, Matthias Frei, Alexander Solms, Corina Becker, Dirk Garmann, and Michaela Meyer are employees of Bayer AG and may own stock in the company. Maria E. Trujillo is an employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and and may own stock in Merck & Co., Inc., Rahway, NJ, USA.
: Funding for this research was provided by Bayer AG, Berlin, Germany, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
: 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, time point, and process of data access. As such, Bayer commits to sharing, upon request from qualified scientific and medical researchers, subject-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients 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 1 January 2014. Interested researchers can use ExternalRef removed to request access to anonymized subject-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 subject-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.
: The R code used to analyze the data is available upon reasonable request by email to the corresponding author.
: The analysis was conducted using linear mixed-effects algorithms implemented in the lme4 or nlme R-packages (R, the R Foundation for Statistical Computing, version 3.2.5, lme4 version1.1-11) with the Navigator workbench (Mango solutions, version 9.4.2) on a Red Hat Enterprise Linux 6.3 environment.
: All authors contributed to the conception, design, or planning of the study. Corina Becker contributed to the acquisition of the data. Hauke Ruehs performed the data analysis and all authors contributed to the interpretation of the data. All authors contributed to writing the manuscript, commented on previous versions of the manuscript, and read and approved the final manuscript.
: This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonisation (ICH) guideline E6: Good Clinical Practice (GCP), and met all local legal and regulatory requirements.
: All subjects provided informed consent.
: Responsibility for opinions, conclusions, and data interpretation lies with the authors, and all authors provide consent for publication.