Bayer, Otmar
,
Adrion, Christine http://orcid.org/0000-0003-2408-2533
Al Tawil, Amani
Mansmann, Ulrich
Strupp, Michael
Funding for this research was provided by:
Bundesministerium für Bildung und Forschung (01EO0901)
Article History
Received: 20 March 2019
Accepted: 12 November 2019
First Online: 30 December 2019
Ethics approval and consent to participate
: Written informed consent was obtained from all participants before initiation of the first study-specific procedure. The study protocol, including the patient information and consent form, was approved by the local ethics committee of each participating institution (leading ethics committee: ethics committee of the Medical Faculty of the Ludwig-Maximilians-Universität, Munich, Germany; reference number: 152–11 fed) and by Germany’s Federal Institute for Drugs and Medical Devices (BfArM; project number 4037229). Clinical trial authorisation was granted on 1 September 2011 (sponsor’s protocol code number: VMMET009). The trial was performed in accordance with the Declaration of Helsinki and other applicable guidelines, laws, and regulations.
: Consent forms for the trial included consent for publication of results in peer-reviewed journals.
: All authors have completed the ICMJE uniform disclosure form at ExternalRef removed (available on request from the corresponding author). MS is Joint Chief Editor of the <i>Journal of Neurology</i>, Editor in Chief of <i>Frontiers of Neuro-otology</i> and Section Editor of <i>F1000</i>. He has received speaker’s honoraria from Abbott, Actelion, Auris Medical, Biogen, Eisai, Grünenthal, GSK, Henning Pharma, Interacoustics, MSD Sharp & Dohme, Otometrics, Pierre-Fabre, TEVA GmBH, and UCB. He is a shareholder in IntraBio. He acts as a consultant for Abbott, Actelion, AurisMedical, Heel, IntraBio and Sensorion. The remaining authors declare that they have no competing interests.