Funding for this research was provided by:
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (4078P0 198403 / 1)
Pharming Biotechnologies B.V.
University Hospital Basel
Received: 8 December 2020
Accepted: 14 December 2020
First Online: 4 January 2021
Ethics approval and consent to participate
: The study has been approved in Switzerland by the lead ethics committee «Ethikkommission Nordwest- und Zentralschweiz» (EKNZ) and the local ethics committees «Ethikkommission Ostschweiz» (EKOS) and «Kantonale Ethikkommission Zürich» (reference number 2020- 01252) on 07.07.2020(ExternalRef removed)The study has been approved by the National Research Ethics Commission (Comissâo Nacional de Ética Em Pesquisa, CONEP) (reference number 4.284.895) on September 18 2020.The study has been approved in Mexico by the Comisión Federal Para La Protección Contra Riesgos Sanitarios (COFEPRIS) (reference number 203301410A0200/2020) on November 03 2020.We hereby certify that this trial has received ethical approval from the ethical committees mentioned above. We will obtain written informed consent from all participants prior to inclusion in the study. This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP or ISO EN 14155 (as far as applicable) as well as all national legal and regulatory requirements.
: Not applicable.
: MT reports receiving grants from the Swiss National Science Foundation, and having research collaborations with Roche, Novartis, and Idorsia outside the submitted work.WCA reports receiving fees and research grants from A. Vogel AG and fees for attendance of advisory boards to MSD and Vifor Pharma that were paid to his institution outside the submitted work.MO reports receiving consulting fees from Pharming Biotechnologies B.V. during the conduct of the study and grants from Pharming Biotechnologies B.V. outside the submitted work.LH reports receiving consulting fees from GlaxoSmithKline and Novartis during the conduct of the study but unrelated to this trial.All other authors have declared no competing interests.