Text and Data Mining valid from 2019-02-09
Accepted: 25 January 2019
First Online: 9 February 2019
Compliance with Ethical Standards
: The trial was performed according to the German Medical Device Act and the Declaration of Helsinki, was registered in the German Clinical Trial Register (DRKS-ID: DRKS00010825), and was approved by the Institutional Review Board of the Freiburg Ethics Commission International (Code: 016/1245).
: The trial was funded by URSAPHARM Arzneimittel GmbH. Peter Meiser is employed at URSAPHARM Arzneimittel GmbH. The authors have declared that there is no further conflict of interest.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
: Informed consent was obtained from all individual participants included in the study.