Cooper, Owen Alan Edwards
Ghatnekar, Ola
Piglowska, Natalia
Smith, Charlie A.
Swinburn, Paul http://orcid.org/0000-0002-3303-5934
Catto, James W. F.
Niegisch, Günter
Jakobsen, Jørn Skibsted
Article History
Accepted: 16 January 2023
First Online: 3 February 2023
Declarations
:
: This research study and manuscript was conducted and written by Evidera by PPD, being funded in full by Ferring Pharmaceuticals.
: Owen Alan Edwards Cooper, Natalia Piglowska, Charlie Smith and Paul Swinburn are employees of Evidera PPD, a CRO paid by Ferring Pharmaceuticals A/S to conduct this study. Ola Ghatnekar and Jørn Skibsted Jakobsen are employees of Ferring Pharmaceuticals A/S. James Catto received honoraria for membership of advisory boards for Ferring Pharmaceuticals A/S. Günter Niegisch received consulting fees from Ferring Pharmaceuticals A/S.
: All procedures and materials were approved by an independent institutional review board (Ethical & Independent Review Services; study number 21084). This study was conducted according to the Declaration of Helsinki.
: All participants provided written informed consent before entering the study.
: All authors of this manuscript consented for publication.
: Health states descriptions are provided in a supplementary file. All other documents will be available on request.
: Not applicable.
: All authors meet the requirements for authorship as specified by the International Committee of Medical Journal Editors (ICMJE) guidelines. All authors have read and approved the final version of the manuscript, and agree to be accountable for the work. OC, NP, CS and PS drafted and finalized the manuscript. OG, JC, GN and JSJ reviewed the manuscripts and provided comments.