Funding for this research was provided by:
Bundesministerium für Bildung und Forschung (01GL1701D, 01GL1701A, 01GL1701C, 01GL1701B)
Text and Data Mining valid from 2019-08-30
Received: 3 April 2019
Accepted: 8 August 2019
First Online: 30 August 2019
Ethics approval and consent to participate
: The study complies with the Declaration of Helsinki, the guidelines on good clinical practice (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), the Memorandum for Safeguarding Good Scientific Practice (German Research Foundation), the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences and WHO), and the CONSORT Statement of recommendations for reporting trials. An independent advisory board was established with patient and public involvement representatives as well as scientific experts, who review the adherence to these guidelines during the entire course of the study.Only subjects who provide valid written informed consent or for whom assent is provided will be included. Thus, prior to participation, all potential participants will receive oral and written information on the study, including information on data protection procedures and potential risks and benefits. Since one of the inclusion criteria for our study is cognitive impairment, a procedure is followed for obtaining valid informed consent. If the patient is incapable of giving informed consent, their legal representative or informal caregiver will be asked to provide informed assent.Ethical approval for this trial was obtained from the ethics committee of Greifswald Medical School (registry number: BB 159/17) and the ethics committee of the Chamber of Physicians of Westphalia-Lippe (registry number: 2017–688-b-S). The trial is registered at ClinicalTrials.gov (NCT03359408).
: Not applicable.
: The authors declare that they have no competing interests.