Ethics approval and consent to participate
ICH
The trial was carried out in compliance with the approved clinical trial protocol, which was in accordance with the principles of the Declaration of Helsinki, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines, applicable regulatory requirements, and Boehringer Ingelheim standard operating procedures. All participants provided informed written consent in accordance with the ICH GCP and local legislation. All patients had to be able to give informed consent personally and have the capacity for such consent. Each patient also had to have a trial partner who was required to consent separately. The study protocol was reviewed and approved by the local independent ethics committees and relevant local authorities.