Garcia-Lopez, Luis-Joaquin
Jimenez-Vazquez, David
Muela-Martinez, Jose-Antonio
Piqueras, Jose A.
Espinosa-Fernandez, Lourdes
Canals-Sans, Josefa
Vivas-Fernandez, Manuel
Morales-Hidalgo, Paula
Diaz-Castela, Maria-Mar
Rivera, Maria
Ehrenreich-May, Jill
Funding for this research was provided by:
Agencia Estatal de Investigación (PID2019-111138RB-I00/AEI/10.13039/501100011033)
Article History
Accepted: 8 November 2023
First Online: 14 December 2023
Declarations
:
: In order to test the efficacy and efficiency of PROCARE-I, we followed the Consolidated Standards of Reporting Trials (CONSORT: ExternalRef removed) and the SPIRIT guidelines (Standard Protocol Items: Recommendations for Intervention Trials). The study was registered at the ClinicalTrial.gov database: ClinicalTrials.gov Identifier: NCT05252026. PROCARE-I received IRB approval and research was authorized by the bioethics committee of the University of Jaen (ID: GEN-3461-aab8-41a3-85c2-ca28-5102-cdda-8d53). The trial was planned according to internationally adopted guidelines (ICH-E6, E8 and E9), being also considered other guidelines, e.g., from the European Medicine Agency (EMA). PROCARE-I adhered to current data protection legislation (Regulation (EU) 2016/679).
: Informed consent was obtained from all individual participants included in the study. In addition, written informed consent was obtained from the parents of the underage participants.
: The authors have no conflicts of interest to declare that are relevant to the content of this article.