Caldas Afonso, Alberto
Gouveia, Catarina
Januário, Gustavo
Carmo, Mafalda
Lopes, Hugo
Bricout, Hélène
Gomes, Catarina
Froes, Filipe
Article History
Received: 19 April 2023
Accepted: 9 October 2023
First Online: 18 January 2024
Declarations
:
: CG and HB are Sanofi employees. MC and HL are IQVIA employees. GJ reports personal fees from Sanofi outside the submitted work. FF reports Advisory Board and personal fees from Sanofi, Pfizer, MSD, Gilead and personal fees or non-financial support from Bial, AstraZeneca, GSK, Novartis, Boehringer Ingelheim, Tecnifar, Lilly, Bayer and Roche outside the submitted work. ACA and CG have no conflicts of interest to declare.
: The study was conducted following the ethical principles of the Declaration of Helsinki and as per local regulations, including privacy laws. Data were provided anonymized and may be used for research purposes without the approval of an ethics committee or informed consent. In addition, the protocol of the BARI study was validated by a panel of clinical experts, classified by the Agency of Medicines and Medical Devices as an observational study, and approved by the Ethics Committee of Hospital Clinic de Barcelona (<i>Comité de Ética de la Investigación con medicamentos del Hospital Clínic de Barcelona</i>, HCB/2020/1132), which waived the need for participant consent as the study fulfills the criteria established on <i>Orden</i> SAS/3470/2009.
: NA.
: NA.