Al Jaghsi, Ahmad http://orcid.org/0000-0002-7888-1149
Heinemann, Friedhelm
Biffar, Reiner
Mundt, Torsten
Funding for this research was provided by:
3 M Deutschland GmbH, Germany
Article History
Received: 7 February 2020
Accepted: 19 May 2020
First Online: 12 June 2020
Compliance with ethical standards
: The study was designed according to the Good Clinical Practice guidelines (ICG-GCP) and the principles of the Declaration of Helsinki, as revised in 2008. The protocol of the RCT followed the SPIRIT guidelines.
: The authors declare that they have no competing interests.
: The study was approved by the Ethics Committee of the University of Greifswald (BB 058/13A) and, secondarily, by the authorized Ethics Committees of the other centers (Ethics Committee of the Medical Council Nordrhein No. 2013336; Ethics Committee of the Medical Council Westfalen-Lippe, 2013-406-b-S).
: Informed consent was obtained from all individual participants included in the study.
: The company did not participate in the study design, data assessment and analysis, decision to publish, or the manuscript preparation. The final decision on content was retained only by the authors.