Wiebe, Sabrina T.
Giessmann, Thomas
Hohl, Kathrin
Schmidt-Gerets, Sven
Hauel, Edith
Jambrecina, Alen
Bader, Kerstin
Ishiguro, Naoki
Taub, Mitchell E.
Sharma, Ashish
Ebner, Thomas
Mikus, Gerd
Fromm, Martin F.
Müller, Fabian
Stopfer, Peter http://orcid.org/0000-0003-0144-0895
Funding for this research was provided by:
Boehringer Ingelheim
Article History
First Online: 5 June 2020
Compliance with Ethical Standards
:
: The study was funded by Boehringer Ingelheim Pharma GmbH & Co. KG, the sponsor of the trial.
: Kathrin Hohl and Edith Hauel were contracted by Boehringer Ingelheim as external statistician and external medical writer, respectively. Alen Jambrecina was the Principal Investigator contracted by Boehringer Ingelheim. Gerd Mikus and Martin F. Fromm have paid consultancy agreements with Boehringer Ingelheim. All other authors are employees of Boehringer Ingelheim.
: The clinical trial protocol was approved by the Independent Ethics Committee of the Chamber of Physicians of Hamburg, Germany, and the Federal Institute for Drugs and Medicinal Products (BfArM). The trial was carried out in compliance with the principles of the Declaration of Helsinki and in accordance with the International Council for Harmonization Guidelines for Good Clinical Practice.
: All subjects in the study provided written informed consent.