Document is current

Article History

Accepted: 16 January 2023

First Online: 18 February 2023

Declarations

:

: This trial was sponsored by Ipsen.

: L.D.: Pharmacokinetic Consultant for Ipsen; N.H.: Research Investigator for Ipsen; D.G.: Chief Medical Officer and shareholder of Clementia; J.O.: employee of Ipsen; K.-H.L.Q.S.: Coordinator of Ipsen FOP program and MO trial.

: Substantial contributions to study conception and design: L.D., N.H., D.G., J.O., K.-H.L.Q.S.; substantial contributions to analysis and interpretation of the data: L.D., N.H., D.G., J.O., K.-H.L.Q.S.; drafting the article or revising it critically for important intellectual content: L.D., N.H., D.G., J.O., K.-H.L.Q.S.; final approval of the version of the article to be published: L.D., N.H., D.G., J.O., K.-H.L.Q.S.

: This trial was approved by the Institutional Review Board, carried out in accordance with the Declaration of Helsinki and the International Council for Harmonisation Good Clinical Practice guidelines.

: All participants provided written and signed informed consent before engaging in any trial procedure.

: Not applicable.

: Qualified researchers may request access to patient-level study data that underlie the results reported in this publication. Additional relevant study documents, including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications may also be made available. Patient-level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the USA and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later. Further details on Ipsen’s sharing criteria, eligible studies, and process for sharing are available here (). Any requests should be submitted to for assessment by an independent scientific review board.

: The authors thank Tom Gleeson PhD, Emma Warnants MBiomedSci, and Emma Lockyer MChem, of Costello Medical, UK, for providing medical writing and editorial support, which was sponsored by Ipsen in accordance with Good Publication Practice guidelines.