Carrasco, Rodrigo
Ramirez, María Cristina
Nes, Kjersti
Schuster, Andrés
Aguayo, Rubén
Morales, Marcelo
Ramos, Cristobal
Hasson, Daniel
Sotomayor, Camilo G.
Henriquez, Pablo
Cortés, Ignacio
Erazo, Marcia
Salas, Claudio
Gormaz, Juan G. http://orcid.org/0000-0003-3424-4807
Funding for this research was provided by:
Fondo de Fomento al Desarrollo Científico y Tecnológico (11150999)
Article History
Received: 14 March 2019
Accepted: 5 December 2019
First Online: 4 February 2020
Ethics approval and consent to participate
: This protocol, in its first version and still valid, was approved and has been monitored by the University of Chile Ethics Committee (identifier: 2082015) since 28 December 2015. Written informed consent was obtained from all patients prior to trial participation. In case of amendments to the protocol, approval will be requested to the aforementioned ethics committee. Subsequently, the investigators, trial participants and trial registries will be informed. A Data Monitoring Committee (DMC) was not implemented in this trial because of the small sample size, easily controlled interventions with a low incidence of side effects. However, the research team will collect, assess reports and manage the data monitoring and reported adverse events. Any data, forms, reports, results and other records will be identified only with a participant identification number to maintain confidentiality. All records will be kept in a locked file cabinet. All computer and networking entries will be done using identification number only, where possible. All computers that contain records are password-protected. Information will not be released without written permission of the participants, except as necessary for monitoring by the Ethics Committee or Local Health Authority.
: Not applicable
: The authors declare that they have no competing interests.