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Article History

Received: 21 February 2023

Accepted: 21 July 2023

First Online: 19 August 2023

Declarations

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: Informed and enlightened consent will be obtained from all study participants. One original copy of the information note and signed consent will be given to the patient, and the other original copy will be retained by the investigator as part of the study documents in an area inaccessible to third parties.The sponsor and the investigator will ensure that this research is carried out in accordance with the law no. 2012–300 of March 5, 2012, relating to research involving the human being, as well as in agreement with Good Clinical Practice (ICH version 4 of November 9, 2016, and decision of November 24, 2006) and the Declaration of Helsinki (which can be found in its full version at ). Except in emergency situations requiring the implementation of specific therapeutic acts, the investigators undertake to respect the protocol in all points, especially with regard to the collection of consent and notification and follow-up of serious adverse events. This research received approval from the Committee for the Protection of Persons (CPP) Ouest I Ethics Committee on April 27, 2022 (ID-RCB: 2021-A03136-35), and was the subject of information to the ANSM. The University Hospital of Bordeaux, sponsor of this research, has taken out a civil liability insurance policy with has taken out insurance for liability insurance in case of damage with the company Lloyd’s Insurance Company SA in accordance with the provisions of the Public Health Code. The data recorded during this research will be recorded in digital format in the UroCCR database (which was authorized by the National Commission for Information Technology and Civil Liberties (CNIL) on 12/04/2013 (authorization request no. 912578, decision DR-2013-206) with respect to law no. 78–17 of January 6, 1978, relating to data processing, files, and freedoms modified by law 2004–801 of August 6, 2004. This research falls within the framework of “Reference Methodology” (MR-001) in the application of the provisions of article 54 paragraph 5 of the amended law of January 6, 1978, relating to information, files, and freedoms. This change was approved by decision of January 5, 2006, updated on July 21, 2016. The Bordeaux University Hospital signed a commitment of conformity to this “Reference Methodology.”

: The authors declare that they have no competing interests.