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Accessed 18 Apr 2023."}],"container-title":["Clinical Pharmacokinetics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40262-024-01384-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40262-024-01384-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40262-024-01384-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,3]],"date-time":"2024-07-03T06:41:47Z","timestamp":1719988907000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40262-024-01384-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6]]},"references-count":66,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2024,6]]}},"alternative-id":["1384"],"URL":"https:\/\/doi.org\/10.1007\/s40262-024-01384-1","relation":{},"ISSN":["0312-5963","1179-1926"],"issn-type":[{"value":"0312-5963","type":"print"},{"value":"1179-1926","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6]]},"assertion":[{"value":"8 May 2024","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"25 June 2024","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This work was funded by Bayer AG, Wuppertal, Germany and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"AF, MM, LR, and CB are employees of Bayer AG and may own stock and\/or stock options in Bayer AG. MB was an employee of Bayer AG at the time of the studies. ROB, MET, and EK are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and may own stock and\/or stock options in Merck & Co., Inc., Rahway, NJ, USA.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Animal experiments described in paragraph one of Sect.  were conducted in accordance with German animal welfare laws, approved by local authorities, and performed in accordance with the ethical guidelines of Bayer AG. Experiments investigating the clinical pharmacokinetic profile of vericiguat in rodents and canines (paragraph three of Sect. ) were performed in accordance with the respective local legal Animal Protection Law and effective government requirements (approval no. 820\/A51). In vivo assessments of QT\/QTc (paragraph one of Sect. ) were conducted with local approval and conformed to the guidelines from Directive 2010\/63\/EU of the European Parliament on the protection of animals used for scientific purposes, or the National Institutes of Health Guide for the Care and Use of Laboratory Animals.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Informed consent was obtained from all individual participants included in the studies.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"Availability of the data underlying this publication will be determined according to Bayer\u2019s commitment to the EFPIA\/PhRMA \u201cPrinciples for responsible clinical trial data sharing\u201d. 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 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 01, 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 member 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.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}}]}}