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Article History

Received: 12 June 2023

Accepted: 29 July 2023

First Online: 10 August 2023

Declarations

:

: This study was approved by the Research and Institutional Ethics Committee of the Faculty of Medicine of Pontificia Universidad Javeriana during the regular session held on October 12^th, 2022 Approval (18/2022). Written, informed consent to participate will be obtained from all participants. The study will be conducted in strict accordance with the guidelines of Good Clinical Practice (GCP) established by the International Conference on Harmonization (ICH). It will adhere to the relevant regulations governing the conduct of clinical studies and the ethical principles outlined in the Declaration of Helsinki. Furthermore, the study will comply with Colombian Resolution No. 008430 of 1993, which establishes the scientific, technical, and administrative standards as requirements for conducting research activities. These comprehensive guidelines and regulations ensure the study's integrity, patient safety, and ethical conduct throughout the research process. The Supplementary InternalRef removed file contains the checklist for the Study Protocols (SPIRIT) 2013 recommendations [CitationRef removed].

: N/a: This protocol does not include the publication of any details, images, or videos.

: S.F. and C U. are inventors of a granted patent related to Esperanza. Authors S.F., C.U. and R.B.-R. are partners of the DreemBio company who was a licensee of related patents. PP, JS, MA, ES and PA declare that they have no competing interests.