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Authors
Jung, Boris http://orcid.org/0000-0003-2522-1531
Fosset, Maxime
Amalric, Matthieu
Baedorf-Kassis, Elias
O’Gara, Brian
Sarge, Todd
Moulaire, Valerie
Brunot, Vincent
Bourdin, Arnaud
Molinari, Nicolas
Matecki, Stefan
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Funding
Funding for this research was provided by:
ADENE (ADENE)
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Article History
Received: 5 February 2024
Accepted: 12 May 2024
First Online: 18 June 2024
Declarations
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: The study protocol and statistical analysis plan was approved by a central ethics committee (Comité de Protection des Personnes Sud Méditerranée, Nice, France, 2017002504-27) in accordance with both French law and the Declaration of Helsinki. We obtained written informed consent from the patient or a relative upon study inclusion. However, considering the severity of the illness, the central ethics committee allowed the investigators to collect a proxy consent with a subsequent written permission to pursue the research obtained from the patient. The French National Agency for Safety in HealthCare (ANSM) oversaw the research protocol and the potential safety issues. An independent steering committee oversaw the research protocol and performed a preplanned safety analysis after half of the patients were enrolled. The protocol was registered (ClinicalTrial.gov NCT03460015, submitted 2018-03-02).
: Not applicable.
: Elias Baedorf-Kassis received speaking fees from Hamilton Medical outside the scope of the present manuscript. Brian O’Gara received honorarium from Sedana Medical. Boris Jung received travel reimbursement and speaking fees from Sedana Medical.
