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Authors
Raffard, Stéphane https://orcid.org/0000-0001-5563-0323
Rainteau, Nicolas
Bayard, Sophie
Laraki, Yasmine
Norton, Joanna
Capdevielle, Delphine
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Funding
Funding for this research was provided by:
Agence Nationale de la Recherche (PHRCN-18-0066)
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Article History
Received: 29 April 2020
Accepted: 12 July 2020
First Online: 17 September 2020
Ethics approval and consent to participate
: This study was approved by the French ethics committee (CPP Est II, CHRU Besançon, France) in January 2020 (CNRIPH: 19.11.29.43226), and site initiation is currently ongoing. It is anticipated that all sites will be initiated within the next 6 months.Informed consent form will be obtained from all study participants before any study procedures are performed. In accordance with GCP, prior to collecting the consent form or the non-opposition form, the subject or subject’s legal representative will be informed by appropriate study personnel about all aspects of the trial that are relevant to making the decision to participate, and will have sufficient time and opportunity to ask any questions. Subjects will be clearly and fully informed about the purpose, potential risks, and other critical issues regarding the clinical studies in which they have volunteered to participate. The consent forms will include consent for the biological sampling, as this analysis is part of the scope of this study (inflammation as a bio-marker of potential efficacy of the ENERGY intervention) and is not considered ancillary to this study.Documentation of the discussion will be recorded in the subject’s medical record. Documentation of the consent process will be recorded in the source documents<i>.</i>The subject will be informed that he/she should notify the investigator of any other medical measures during the study period and that he/she cannot simultaneously take part in another study without informing the investigator.Subjects must also be informed that participation is voluntary and that they may withdraw from the study at any time, without prejudice to their current or future care. Documentation of the discussion and the date of informed consent must be recorded in the subject’s medical record.Up to this date there are no additional studies planned using the participants’ data and/or biological specimens. Any additional studies using the participants’ data will require a new clinical protocol and will be submitted to the IEC/IRB for approval.
: Not applicable.
: The authors declare that they have no competing interests.
