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Article History

Received: 26 July 2022

Accepted: 30 May 2023

First Online: 8 June 2023

Declarations

:

: The study was conducted following the ethical principles of the Declaration of Helsinki and local regulations, including privacy laws. The protocol of the BARI study was validated by a panel of clinical experts, classified by the Agency of Medicines and Medical Devices (AEMPS) as an observational study, and approved by the Ethics Committee of the Hospital Clinic de Barcelona (HCB/2020/1132). Informed consent to participate was waived by the same ethics committee that approved the study (Ethics Committee of the Hospital Clinic de Barcelona).

: NA.

: Platero L, Drago G, López-Belmonte JL and Bangert M are Sanofi employees and may hold shares and/or stock options in the company. Carmo M is an IQVIA employee. Martinón Torres F and Díez-Domingo J have received fees from Sanofi. F.M-T. received honoraria from GSK group of companies, Pfizer Inc, Sanofi Pasteur, MSD, Seqirus, and Janssen for taking part in advisory boards and expert meetings and for acting as a speaker in congresses outside the scope of the submitted work. FM-T has also acted as principal investigator in randomized controlled trials of the above-mentioned companies as well as Ablynx, Gilead, Regeneron, Roche, Abbott, Novavax, and MedImmune, with honoraria paid to his institution. F.M-T has received support for the present work from the Instituto de Salud Carlos III (Proyecto de Investigación en Salud, Acción Estratégica en Salud): Fondo de Investigación Sanitaria (FIS; PI070069/PI1000540/PI1601569/PI1901090) del plan nacional de I + D + I and ‘fondos FEDER’ and Proyectos GaIN Rescata-Covid_IN845D 2020/23 (GAIN, Xunta de Galicia).