Nze Ossima, Arnaud
Ngaleu Siaha, Bibi Fabiola
Mimouni, Maroua
Mezaour, Nadia
Darlington, Meryl
Berard, Laurence
Cachanado, Marine
Simon, Tabassome
Freund, Yonathan
Durand-Zaleski, Isabelle
Funding for this research was provided by:
Ministry of Health, France (PHRC 2017)
Article History
Received: 21 March 2023
Accepted: 11 November 2023
First Online: 29 November 2023
Declarations
:
: Approval of the study was obtained by the appropriate ethics committees in Spain and France (Comite de Etica de la Investigacion con Medicamentos del Hospital Clinic de Barcelona and Comite de Protection des Personnes Ile-de-France XI). Informed consent was sought for each patient before inclusion in the study: oral in France because written consent is not requestd in cluster randomization, and written in Spain.
: This study is based upon a clinical trial using cluster randomization which makes individual consent unnecessary. All eligible patients were informed of the study by an information form in participating centers. The treating physician or the local investigator explained the rationale and objectives of the study. An information note was given. Patient expressed oral consent before being included in the study. The Modiglia NI clinical trial was performed in accordance with the Declaration of Helsinki.
: Not applicable.
: Dr Simon reported receiving grants from the FrenchMinistry of Health, AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Eli Lilly, GlaxoSmithKline,Novartis, and Sanofi; personal fees from AstraZeneca, Ablative Solutions, Bayer, Novartis, Sanofi, and 4Living Biotech; and fees for conferences, counseling, and/or research grants from Merck Sharp & Dohme, Amgen, and Sanofi outside the submitted work. Dr Durand-Zaleski reported receiving grants from the French Ministry of Health, personal fees for conferences, counselling from Air Liquide, Amgen, BMS, Merck Sharp & Dohme, Pfizer, Takeda outside the submitted work. No other disclosures were reported. Dr Durand-Zaleski reported receiving grants from the French Ministry of Health, personal fees for conferences, counselling from Air Liquide, Amgen, BMS, Merck Sharp & Dohme, Pfizer, Takeda outside the submitted work. No other disclosures were reported.