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Ute Burkard is an employee of Boehringer Ingelheim Pharma GmbH & Co. KG. Carl Coeck is an employee of Boehringer Ingelheim SComm.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"To ensure independent interpretation of clinical trial results and enable authors to fulfill their role and obligations under the ICMJE criteria, Boehringer Ingelheim grants all external authors access to clinical study data pertinent to the development of the publication. In adherence with the Boehringer Ingelheim policy on transparency and publication of clinical study data, scientific and medical researchers can request access to clinical study data, typically, 1\u00a0year after the approval has been granted by major regulatory authorities or after termination of the development programme. Researchers should use the\n                      \n                      link to request access to study data and visit\n                      \n                      for further information.","order":2,"name":"Ethics","label":"Availability of Data and Material","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The trials were carried out in accordance with the principles of the Declaration of Helsinki, in accordance with the International Council on Harmonisation\u2014Good Clinical Practice guidelines, and in accordance with applicable regulatory requirements and Boehringer Ingelheim standard operating procedures. All subjects were informed about the trial, both verbally and in writing, by the investigator. All participants provided signed and dated informed consent forms according to the local regulatory and legal requirements. 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