Boettcher, Michael http://orcid.org/0000-0001-8931-4564
Nowotny, Bettina http://orcid.org/0000-0002-0671-9644
Krausche, Robert
Becker, Corina http://orcid.org/0000-0003-4715-6726
Funding for this research was provided by:
This study was funded by Bayer AG and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA
Article History
Accepted: 12 December 2022
First Online: 2 February 2023
Change Date: 13 May 2023
Change Type: Update
Change Details: The original online version of this article was revised to include the electronic supplementary material.
Declarations
:
: This study was funded by Bayer AG and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (MSD).
: Corina Becker and Bettina Nowotny are employees of Bayer AG. Michael-Friedrich Boettcher is a former employee of Bayer AG and has received within the last 36 months, salary, pension, and payment for writing and reviewing vericiguat manuscripts from Bayer AG and for lectures, exercises, and awarding and supporting bachelor and master theses. Robert Krausche is an employee of Chrestos Concept GmbH & Co. KG and was paid by Bayer AG to perform the statistical analyses.
: The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonisation guideline E6: Good Clinical Practice and met all local legal and regulatory requirements.
: All patients provided written informed consent before any study procedure was performed.
: 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 subject-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in volunteers 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 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 volunteer privacy is safeguarded.
: Not applicable.
: All authors contributed to the conception, design, or planning of the study. MB, BN, and CB contributed to the acquisition of the data. RK 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.