Jayankura, Marc http://orcid.org/0000-0002-5854-7071
Schulz, Arndt Peter
Delahaut, Olivier
Witvrouw, Richard
Seefried, Lothar
Berg, Bruno Vande
Heynen, Guy
Sonnet, Wendy
Funding for this research was provided by:
Bone Therapeutics SA
The Walloon Region
Article History
Received: 30 December 2020
Accepted: 6 June 2021
First Online: 26 June 2021
Declarations
:
: The study was performed in accordance with the current version of the Declaration of Helsinki (Fortaleza, Brazil, October 2013). The trial was conducted in agreement with the International Council on Harmonisation guidelines on Good Clinical Practice. The study protocol, all its amendments and the patient information sheet(s) were reviewed and approved by the appropriate Ethics Committees (CUB-ULB Erasme, Brussels, in Belgium and Universitätsklinikum Köln in Germany).This study was conducted in seven centres in Belgium and Germany (CUB-ULB Hôpital Erasme, Belgium; CHU de Charleroi, Belgium; CHU St Pierre, Belgium; Ziekenhuis Oost-Limburg, Belgium; Klinikum rechts der Isar der TU München, Germany; Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Germany; Universität Würzburg, Germany). A written, dated and signed informed consent was obtained from all patients or patients’ legally acceptable representatives prior to any study procedure.
: Not applicable.
: MJ, APS, OD, RW and LS declare having received fees for the study conduct from Bone Therapeutics to cover their principal investigator activities.BVB declares having received fees for consultancy and radiological reading from Bone Therapeutics.GH is an employee of Bone Therapeutics and owns shares in the company.WS is an employee of Bone Therapeutics.