Warner, Sarah E.
Kaplan, Frederick S.
Pignolo, Robert J.
Smith, Stacy E.
Hsiao, Edward C.
De Cunto, Carmen
Di Rocco, Maja
Harnett, Kathleen
Grogan, Donna
Genant, Harry K.
Funding for this research was provided by:
Ipsen
Article History
Received: 26 March 2021
Accepted: 9 June 2021
First Online: 31 July 2021
Declarations
:
: SEW: Employee of PAREXEL International (dba Calyx); FSK: Research investigator: Ipsen, Regeneron; Advisory board: IFOPA Medical Advisory Board; Founder and Immediate Past-President of the International Clinical Council (ICC) on FOP; Chair of the Publications Committee of the ICC; RJP: Research investigator: Ipsen, Regeneron; Advisory board: President of the International Clinical Council on FOP; Chair of the Publications Committee for the IFOPA Registry Medical Advisory Board; SES: None declared; ECH: Advisory board (all voluntary): Fibrous Dysplasia Foundation, IFOPA Registry Medical Advisory Board, International Clinical Council on FOP; Research support: International FOP Association, Ipsen, National Institutes of Health, Radiant Hope Foundation; Prior research support: Regeneron, Neurocrine Biosciences Inc; Research investigator: Ipsen; CDC: Research investigator: Ipsen; MDR: Advisory board: Ipsen; Research investigator: Ipsen, Regeneron; HKG: Consultant for Agnovos, Amgen, AstraZeneca, Bioclinica, BioMarin, Ipsen, Medimmune, Medtronic, Radius and Regeneron; KH, DG: Employees of Ipsen.
: Although not a clinical trial involving an investigational agent, this study was conducted in accordance with the principles that have their origin in the Declaration of Helsinki, inclusive of any subsequent amendment(s), and that are consistent with the International Council for Harmonization (ICH) Good Clinical Practice (GCP), European Union Directive 2001/20/EC, United States Food and Drug Administration (FDA) Code of Federal Regulations, and other applicable local regulatory requirement(s), whichever affords greater patient protection. The original protocol, all protocol amendments, and informed consent/assent forms and updates were reviewed and approved by the corresponding Institutional Review Board (IRB) or Independent Ethics Committee (IEC) at each site in accordance with local regulatory requirements.
: Prior to participation in the study, the Investigator and/or delegate fully explained to the patients and/or parents all aspects of the study that were relevant to the decision to participate. Informed consent was documented by means of a written, signed, and dated consent form, prior to study initiation.
: Participants provided informed consent for the anonymized publication of the results of the study.