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Authors
Melero, Alejandro
Torrecilla, Josune
Pino, Ander
Alonso, José María
Coello, Daniel
Sáez de Arregui, Sandra
Garay-Aramburu, Gonzaga
López-Plandolit, Silvia
Guergué, Olaia
Henares, Iker
Huguet-Casquero, Amaia
Ucelay López de Heredia, Miguel
Pérez González, Raúl
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Funding
Funding for this research was provided by:
Basque Country Government (MTVD20/BCB/024)
Basque Government’s Department of Health - Research Intensification Program (2024222008)
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Article History
Received: 23 December 2025
Accepted: 11 May 2026
First Online: 20 May 2026
Declarations
Ethics approval and consent to participate: This study was approved on 8 February 2021 by the Ethics Committee for Research with Medicines of Euskadi (CEIm-E), code PS2020065, which belongs to the Department of Health of the Basque Government (Spain). The protocol (OpHLINE-PIC01-2020), subject information sheet, and informed consent form were reviewed and approved in accordance with the revised World Medical Association Declaration of Helsinki (2013), UNE-EN ISO 14155:2021, and CPMP/ICH-GCP-E6/135/95 guidelines. All participants provided written informed consent prior to enrolment. Trial registration: ClinicalTrials.gov, NCT ID Number NCT07343973, registered on 07 January 2026.
Consent for publication: Not applicable. This manuscript does not contain any individual person’s data in any form.
Competing interests: RP is the Scientific Director and AHC is the Chief Operations Officer of i+Med S.Coop., the company that commercializes OpHLINE ® . AP, JT, AM, JMA and MULH are employees at i+Med S.Coop. The remaining authors declare that they have no competing interests.
