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Authors
Couderc, Anne-Laure http://orcid.org/0000-0003-2938-2201
Villani, Patrick
Berbis, Julie
Nouguerède, Emilie
Rey, Dominique
Rossi, Dominique
Lechevallier, Éric
Badinand, Delphine
Bastide, Cyrille
Karsenty, Gilles
Boissier, Romain
Amichi, Kahena
Muracciole, Xavier
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Funding
Funding for this research was provided by:
Assistance publique-Hôpitaux de Marseille (Not applicable)
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Article History
Received: 7 April 2021
Accepted: 12 December 2021
First Online: 18 January 2022
Declarations
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: The study will be conducted in accordance with the Helsinski declaration and the French laws and regulations (Code de la Santé Publique, article L.1121-1 / Loi de Santé Publique n°2004-806 du 9 août 2004 relative à la politique de santé publique et ses décrets d’application du 27 août 2006) and the International Conference on Harmonization (ICH) E6 Guideline for Good Clinical Practice. Regulatory monitoring will be performed by the sponsor. The sponsor needed the approval of the French authorities, including the French ethics committee (Comité de Protection des Personnes Ile de France IV, approved version 2 of the HoSAGE protocol in date of 14<sup>th</sup> October 2019 reference number 2019/77 - approved on the 24<sup>th</sup> October 2019, the French drug and device regulation agency (Agence Nationale de Sécurité du Médicament, registry number 2019-A02319-48).The ExternalRef removed identifier is NCT04484246 (ExternalRef removed).Informed consent will be obtained from all subjects.
: The authors declare that they have no competing interests.
: Not applicable as this publication doesn’t show patient medical information. Nevertheless all patients are currently signing an informed consent before enrollment.
