Vanya, Magdalena
Watt, Maureen
Shahraz, Saeid http://orcid.org/0000-0003-4550-3843
Kosmas, Charlotte E.
Rhoten, Stephanie
Costa-Cabral, Sara
Mendivil, Joan http://orcid.org/0000-0003-1139-0078
Devercelli, Giovanna
Weller, Karsten http://orcid.org/0000-0003-4437-0313
Funding for this research was provided by:
Shire (N/A)
Article History
Received: 8 November 2022
Accepted: 14 March 2023
First Online: 3 April 2023
Change Date: 5 June 2023
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1186/s41687-023-00587-7
Declarations
:
: MV was a full-time employee of ICON plc at the time of this analysis and is currently an employee of Takeda Development Center Americas. MW is a full-time employee of Takeda Pharmaceuticals International AG and holds stocks/options. SS was an employee of ICON plc at the time of this analysis. CEK is a full-time employee of ICON plc. SR was a full-time employee of IQVIA at the time of this analysis. SC-C is a full-time employee of Mapi Research Trust. JM was a full-time employee of Takeda Pharmaceuticals International AG at the time of this study. GD is a full-time employee of Takeda Development Center Americas and holds stocks/options. KW received payment from ICON as compensation for his participation in a qualitative interview to assess the content validity of the AE-QoL in this research study, and has received research grant support and/or honoraria for educational lectures or consulting from BioCryst, Moxie, Novartis, Pharvaris, and Takeda.
: The study protocol and materials for the patient interviews were reviewed and approved by independent review boards (Salus IRB, Austin, TX, USA and Western Institutional Review Board, Vancouver, BC, Canada) before recruitment. The study was double-blinded; the patients and the sponsor were not informed of each other’s identity. As patients were recruited by a patient recruitment agency and not from individual clinical sites, the US IRB approval extended to cover the EU countries as well.
: Not applicable.