Houben, Philipp http://orcid.org/0000-0001-5234-732X
Khajeh, Elias
Hinz, Ulf
Knebel, Phillip
Diener, Markus K.
Mehrabi, Arianeb
Article History
Received: 16 April 2018
Accepted: 29 June 2018
First Online: 16 July 2018
Ethics approval and consent to participate
: The trial will be carried out in accordance with the 2013 version of the Helsinki declaration. The clinical trial will be conducted in accordance with the European Union’s recommendations on good clinical practice. The trial protocol design is in accordance with the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines [CitationRef removed,CitationRef removed]. Prior to the start of the trial, the study protocol was submitted to the ethics review committee of the medical faculty of the University of Heidelberg for consultation. The respective approval (S-217/2017) was received on May 25, 2017. An approval of protocol changes was received on March 29, 2018. All relevant changes in the protocol will be announced to the ethics review committee. Participation in the trial is voluntary and is not associated with financial rewards or any other implied benefits for the patient. Patients can withdraw their consent to participate in the trial at any time without stating the reasons for withdrawal or being subject to any adverse consequences over the course of their medical treatment. All personal patient information will be subject to professional discretion, according to the German Federal Data Privacy Protection Law (Bundesdatenschutzgesetz [BDSG]) and the European Union General Data Protection Regulation. All data interpretation and transmission will be done only via pseudonyms. None of the data will be made available to third parties. Before participation in the trial, all patients will be informed about the nature, course, and risks of the trial in both written and oral form by an investigator. All potential benefits, hazards, and trial-related risks will be explained in detail. The patients’ consent to participate will be documented via signature on a written informed consent form.
: Not applicable.
: The authors declare that they have no competing interests.
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