Jungo, Katharina Tabea
Meier, Rahel
Valeri, Fabio
Schwab, Nathalie
Schneider, Claudio
Reeve, Emily
Spruit, Marco
Schwenkglenks, Matthias
Rodondi, Nicolas
Streit, Sven
Article History
Received: 12 January 2021
Accepted: 9 June 2021
First Online: 22 June 2021
Declarations
:
: The ethics committee of the canton of Bern (Switzerland) and the Swiss regulatory authority (Swissmedic) approved the study protocol of the OPTCIA trial and other documentation on study conduct (BASEC ID: 2018–00914). The ethics committee and Swissmedic receive annual safety reports and information about study stops/end and protocol amendments, as per local requirements. Written informed consent was obtained from all study participants participating in the OPTICA trial. The OPTICA trial was performed in accordance with relevant guidelines and regulations. The local Ethics Committee of the Canton of Zurich approved studies within the FIRE project database (BASEC-Nr. Req-2017–00797). Due to the anonymized nature of the EHR data in the FIRE database individual patient consent was not required. The analyses presented in this manuscript did not require an additional ethical approval.
: Not applicable.
: The authors do not have any conflicts of interest to declare.