Coste, Astrid
Buffet, Alexandre
Duboeuf, Margaux
Boudif, Sabrina
Grassot, Lény
Ouelaa, Boutheina
Sueur, Annabelle
Lounis, Timgad
Pérol, Olivia
Fervers, Béatrice
Gimenez-Roqueplo, Anne-Paule
Funding for this research was provided by:
Agence Nationale de Sécurité Sanitaire de l’Alimentation, de l’Environnement et du Travail (ANSES, N° 2022-CS-01_PPV22, ANSES, N° 2022-CS-01_PPV22, ANSES, N° 2022-CS-01_PPV22, ANSES, N° 2022-CS-01_PPV22, ANSES, N° 2022-CS-01_PPV22)
Article History
Received: 2 December 2024
Accepted: 25 June 2025
First Online: 2 July 2025
Change Date: 20 August 2025
Change Type: Update
Change Details: The original online version of this Article was revised: In the original version of this Article, the author name Anne-Paule Gimenez-Roqueplo was incorrectly indexed. The original Article has been corrected.
Declarations
:
: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
: French law (in accordance with Articles L1122-1 and L1122-1-1 of the French Public Health Code) requires that participation in research of this nature (non-interventional epidemiological study) be offered to patients after they have been individually informed in writing, with the physician seeking the patient’s opposition to participation, and ensuring traceability of the absence of opposition (“non-objection form”). The law does not require written traceability to be directly ensured by the patient. These procedures have been implemented for this study (PGL.EXPO-1-ClinicalTrials.gov Identifier: NCT04481152) after approval by a committee for the protection of persons, in accordance with the law (Protection of Persons Committee of Ile-de-France X, Ref: 34-2020). It also received a favorable opinion from the French data protection authority, the Commission Nationale Informatique et Libertés (CNIL) (Ref: MLD/MFI/AR2114411). More specifically, before being included in the study, the patient receives a written information. The investigator orally explains to the patient the content of this information note, which consists of presenting the study, explaining its objectives and answering any questions the patient may have. The patient’s consent is given orally to the investigator, following the various items of information provided by the investigator, i.e. “informed consent”, who attests to this on the information note by indicating the following 4 items of information: patient’s surname/first name/identifier in the research; opposition expressed, date of issue of information, signature of person responsible for information.