Document is current

Article History

Received: 5 June 2024

Accepted: 15 November 2024

First Online: 26 February 2025

Declarations

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: Marie Picci, Nigel Cook, Byron Jones, Mo Zhou, Conny Berlin, Christine Sturchler, Clemence Martinez, Irene Garcia Baena and Lauren Ziegler are employed by Novartis and hold Novartis shares. Conny Berlin, Nigel Cook and Byron Jones were also members of the IMI PREFER project. Harriet Gaunt is a full-time employee of Adelphi Research, who received funding from Novartis to draft the FDA briefing document and conduct the post-FDA qualitative interview stage of the study. Brad Mason is a full-time employee of Adelphi Values Patient-Centered Outcomes, who received funding from Novartis to draft the FDA briefing document and conduct the post-FDA qualitative interview stage of the study. Dominique Hamerlijnck is an independent patient expert consultant for Novartis, Chiesi, Pfizer and Roche, mainly on improving patient engagement. None of her family members are employed by Novartis. Yoshiyuki Majima is an independent patient expert consultant for Novartis, representing PanCAN Japan. None of his family members are employed by Novartis.