Bjerre, Anna http://orcid.org/0000-0002-1421-0098
Aase, Sonja Amdal
Radtke, Maria
Siva, Christian
Gudmundsdottir, Helga
Forsberg, Brita
Woldseth, Berit
Brackman, Damien
Funding for this research was provided by:
University of Oslo
Article History
Received: 28 November 2022
Revised: 20 April 2023
Accepted: 20 April 2023
First Online: 23 May 2023
Declarations
:
: Due to the retrospective nature of the study, the Norwegian Ethics Committees assessed the project to be a quality assurance project outside the Health Research Act, and therefore, there was no need to approve the study. The sponsor has also been in contact with the Norwegian Directorate of Health. No approval from them was needed since the patients voluntarily signed the informed consent. This was in accordance with the General Data Protection Regulation (GDPR) art. 7. Before study initiation, the local Privacy Officer at each hospital evaluated the study.
: Chiesi Global Rare Diseases has reimbursed all participating sites, per the number of hours preparing and performing the study. Oslo University Hospital has received speakers’ honoraria and travel grants for Anna Bjerre from Chiesi Global Rare Diseases Nordics. The departments of AB and BW have received consultation fees from Chiesi Global Rare Diseases. All other authors declare no competing interests.