Wong, Diane http://orcid.org/0000-0002-9330-872X
Seitz, Friedeborg http://orcid.org/0000-0002-4460-5867
Bauer, Verena
Giessmann, Thomas
Schulze, Friedrich http://orcid.org/0000-0003-0277-8134
Funding for this research was provided by:
Boehringer Ingelheim
Article History
Received: 4 March 2024
Accepted: 13 May 2024
First Online: 24 May 2024
Declarations
:
: The protocols of both studies were reviewed and received a favorable opinion from the Ethics Committee of the Medical Association (Ethikkommission der Landesaerztekammer) of Baden-Wuerttemberg, Stuttgart, Germany. Subsequently, the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany) reviewed and approved both studies. Both studies were conducted in accordance with the principles of the Declaration of Helsinki, the International Conference on Harmonisation – Good Clinical Practice, applicable regulatory requirements, and standard operating procedures of the trial sponsor.
: All subjects provided written informed consent prior to participation.
: Not applicable.
: Diane Wong, Verena Bauer, Thomas Giessmann, and Friedrich Schulze are employees of Boehringer Ingelheim. Friedeborg Seitz is an employee of CRS Clinical Research Services.