Funding for this research was provided by:
World Bank and Vicerrectoría de Investigaciones, Pontificia Universidad Javeriana (FP44842-221-2018, FP44842-221-2018, FP44842-221-2018, FP44842-221-2018, FP44842-221-2018, FP44842-221-2018, FP44842-221-2018)
Received: 9 July 2023
Accepted: 24 August 2023
First Online: 5 September 2023
: This study received approval from the Research and Institutional Ethics Committee of the Faculty of Medicine of the Pontificia Universidad Javeriana during its session on July 21, 2021 (Approval FM-CIE-0689–21). Following this approval, the study underwent review and approval by the Colombian National regulatory agency, Instituto Nacional de Vigilancia de Medicamentos y Alimentos—INVIMA, through Resolution No. 2022000837 dated January 13, 2022. Approval for phase II by the Research and Institutional Ethics Committee of the Faculty of Medicine of the Pontificia Universidad Javeriana was obtained on October 17, 2022 (FM-CIE-0955–22), allowing for the recruitment of participants in phase II.All participants will be required to provide written informed consent before participating in the study, demonstrating their understanding and willingness to take part. The study will strictly adhere to the guidelines of Good Clinical Practice (GCP) established by the International Conference on Harmonization (ICH). It will also comply with the relevant regulations governing the conduct of clinical studies and follow the ethical principles outlined in the Declaration of Helsinki. Additionally, the study will adhere to Colombian Resolution No. 008430 of 1993, which establishes scientific, technical, and administrative standards as requirements for conducting research activities.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.P.U. are inventors of a granted patent related to P2Et. Authors S.F., C.P.U. and R.B.-R. are partners of the DreemBio company who was a licensee of related patents. PP, JS, PA, and LT declare that they have no competing interests.