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MI has received financial honoraria for lectures from Actelion, AstraZeneca, Bayer AG, Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Pfizer Inc., and research grants from Actelion, AstraZeneca, and Pfizer Inc. MS has received financial honoraria for lectures from Actelion and Bayer AG. DZ has received payments and travel funding for overseas lectures from Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim, and Pfizer. NT is an employee of Bayer AG, Berlin, Germany. KV is an employee of Bayer AG, Wuppertal, Germany. KH, SK, and IS are employees of Institut Dr. Schauerte, Munich, Germany, which was contracted by Bayer AG to develop the eCRF and data capture system and were involved in the collection and analysis of the data. All other authors have nothing to declare.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Availability of the data underlying this publication will be determined according to Bayer\u2019s commitment to the European Federation of Pharmaceutical Industries and Associations and Pharmaceutical Research and Manufacturers of America principles for responsible clinical trial data sharing, pertaining to scope, time point, and process of data access. 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 doing legitimate research. This commitment applies to data on new medicines and indications that have been approved by the European Union and US regulatory agencies on or after January 1, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to do 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.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability statement"}},{"value":"Approval from appropriate independent ethics committees (ECs) and institutional review boards (IRBs) was obtained from all participating centers. The ECs, IRBs, and dates of approval are listed in Supplementary Table 6. The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All patients provided informed, written consent.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"The study protocol and eCRF were developed by Bayer AG. NT oversaw amendments to the protocol and eCRF following discussions with the investigators. HG\u00d6 was the principal investigator throughout the study. HG\u00d6, BA, MAD, AC, GD, MI, EK, HK, VL, TM, NM, MAM, BM, GO, AO, ZP\u00d6, HS, NS, MS, LT, TT, HY, DZ, and AA recruited patients to the study, were responsible for all investigations and treatment decisions according to their clinical judgement and practice, agreed on the refinements to the eCRF, and provided the data to the capture system accordingly. All authors developed and revised the manuscript for important intellectual content at every stage, including interpretation of the data and all phases of manuscript preparation, and they read and approved the final version for submission. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Institut Dr Schauerte managed the electronic data capture system and collected the data. KH, SK, IS, and KV analyzed the results. IS was the project manager for the study at Institut Dr Schauerte.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}