Bettonville, Marie
Léon, Marc
Margaux, Joëlle
Urbin-Choffray, Didier
Theunissen, Emilie
Besse-Hammer, Tatiana
Fortems, Yves
Verlinden, Séverine
Godeaux, Olivier
Delmarcelle, Anne-Sophie
Kaux, Jean-François
Article History
Received: 19 February 2021
Accepted: 3 September 2021
First Online: 19 October 2021
Declarations
:
: The study was performed in accordance with the current version of the Declaration of Helsinki (Fortaleza, Brazil, October 2013) and the International Conference on Harmonization Good Clinical Practice Guideline. The study protocol, its amendments, and the patient information sheet were reviewed and approved by the appropriate independent Ethics Committees (central ethics committee: Comité d’Ethique Erasme-ULB). All participants signed the Informed Consent Form prior to randomization.
: Not applicable.
: MB and A-SD were employees of Bone Therapeutics at the time of the study conduct and manuscript development. OG (ZAM Consulting) worked as an independent consultant as Chief Medical Officer for Bone Therapeutics at the time of the study conduct and manuscript development.ML, JM, DU-C, ET, TB-H, YF, SV and J-FK declare having received fees (or their institutions) for the study conduct from Bone Therapeutics.