Soria-Juan, Barbara
Garcia-Arranz, Mariano
Llanos Jiménez, Lucía http://orcid.org/0000-0003-3443-7182
Aparicio, César
Gonzalez, Alejandro
Mahillo Fernandez, Ignacio
Riera del Moral, Luis
Grochowicz, Lukasz
Andreu, Enrique J.
Marin, Pedro
Castellanos, Gregorio
Moraleda, Jose Maria
García-Hernández, Ana Maria
Lozano, Francisco S.
Sanchez-Guijo, Fermin
Villarón, Eva María
Parra, Miriam Lopez
Yañez, Rosa María
de la Cuesta Diaz, Antonio
Tejedo, Juan Rigoberto
Bedoya, Francisco J.
Martin, Franz
Miralles, Manuel
del Rio Sola, Lourdes
Fernández-Santos, María Eugenia
Ligero, José Manuel
Morant, Francisco
Hernández-Blasco, Luis
Andreu, Etelvina
Hmadcha, Abdelkrim
Garcia-Olmo, Damian
Soria, Bernat
Funding for this research was provided by:
Instituto de Salud Carlos III (PIC 18 / 00010)
Article History
Received: 11 March 2021
Accepted: 7 July 2021
First Online: 6 September 2021
Declarations
:
: This trial has been approved by FJD Ethics Committee (EC) and National Competent Authority (AEMPS) and will be performed in accordance with the Declaration of Helsinki. Written, informed consent to participate will be obtained from all participants. All information collected will be treated strictly confidential, in accordance with current regulations: Organic Law 3/2018 of December 5, Protection of Personal Data and Guarantee of Digital Rights, Regulation (EU) 2016/679 of the European Parliament and of the Council, of April 27, 2016 (GDPR), General Health Law 14/1986 and Law 14/2007 of Biomedical Research, Law 41/2002 of Patient Autonomy. Since it is a clinical trial that uses a not marketed investigational advanced therapy medicinal product, the sponsor of the study has contracted a civil liability insurance policy to cover compensation for potential harms suffered from trial participation. Relevant protocol amendments will be communicated to the investigators after EC and AEMPS approval. The sponsor agrees to publish the study results, either positive or negative, of the clinical trial, preferably in open-access scientific journals before being disclosed to the non-health public. Authorship will be considered following ICMJE guidelines. The rest of personnel involved in the clinical trial but not meeting authorship criteria will be acknowledged in the Contribution section. No hiring of professional writers has been performed to write this manuscript and will not be in the writing of the final study report for publication.
: Not applicable
: The authors declare that they have no competing interests.