González Osuna, Aránzazu http://orcid.org/0000-0002-2436-9035
Rojas, Luisa Fernanda http://orcid.org/0000-0002-7103-1432
Lamas, Claudia http://orcid.org/0000-0001-7073-039X
Aguilera Roig, Xavier http://orcid.org/0000-0001-9398-5635
Pla-Junca, Francesc http://orcid.org/0000-0002-4403-6297
Videla, Sebastián http://orcid.org/0000-0001-5049-1379
Martínez-Zapata, Mª José http://orcid.org/0000-0002-5836-1138
Valle, Marta http://orcid.org/0000-0002-3515-251X
Font Gual, Adriá
González Osuna, Aránzazu
Lamas, Claudia
Ramirez, Eduard
Cánovas Martínez, Esther
Pla-Junca, Francesc
Fernández Nuñez, José Antonio
González Rodriguez, José Carlos
Rojas, Luisa Fernanda
Jordán Sales, Marcos
Rodríguez Prieto, Mireia
Martínez-Zapata, Mª José
Valle, Marta
Videla, Sebastián
Baños Lapuente, Victoria
Aguilera Roig, Xavier
,
Article History
Accepted: 28 May 2021
First Online: 13 July 2021
Declarations
:
: Aránzazu González Osuna, Luisa Fernanda Rojas, Claudia Lamas, Xavier Aguilera Roig, Francesc Pla-Junca, Sebastián Videla, Mª José Martínez-Zapata, and Marta Valle declare they have no conflicts of interest.
: This study was supported by internal sources from the Institut de Recerca Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
: The clinical trial was approved by the Investigational Review Board of Hospital de Santa Creu i Sant Pau, Barcelona, Spain. This study was conducted in accordance with the principles of the Declaration of Helsinki. A high level of confidentiality, in terms of protection of personal data as required by Spanish Law (LOPD 3/2018), was also ensured.
: Patients who agreed to participate signed a written informed consent form.
: Not applicable.
: Research data are not shared.
: Not applicable. The clinical trial protocol was registered in the Spanish Registry of Clinical Studies database (ExternalRef removed; number 2017-004159-22).
: AGO, MV, LFR, XAR, FP-J, MJM-Z, and SV were involved in the conception and design of the study and/or the analysis and interpretation of the data. AGO and XAR were involved in the acquisition of data. MV, LFR and FP-J performed the pharmacokinetics analysis. AGO, MV, LFR, XAR, MJM-Z, and SV wrote the manuscript. All authors revised the article critically for important intellectual content and gave approval for the final version to be published.