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Article History

Received: 7 November 2024

Accepted: 17 February 2025

First Online: 7 March 2025

Declarations

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: The development of the project was carried out respecting the Declaration of Helsinki of the World Medical Association 1964 and ratifications of the following assemblies (Tokyo 75, Venice 83, Hong Kong 89, Somerset West 96, Scotland 00, Seoul 08 and Fortaleza 13) on ethical principles for medical research on human beings, RD 1090/2015, of December 24, on clinical trials, specifically the provisions of article 38 on good clinical practices, and the Convention on human rights and biomedicine), made in Oviedo on April 4, 1997 and successive updates. Researchers participating in this study agreed that all clinical data collected from the study subjects will be separated from personal identification data in such a way as to ensure the anonymity of the patient; respecting the Personal Data Protection Law (Organic Law 15/1999, of December 13), RD 1720/2007 of December 21, which approves the Regulations for the development of Organic Law 15/1999, Law 41/2002, of November 14 (basic regulation of patient autonomy and rights and obligations in terms of information and clinical documentation), as well as Law 3/2001, of May 28, (regulator of informed consent and the clinical history of patients), Law 3/2005, of March 7, modifying Law 3/2001 and Decree 29/2009 of February 5, which regulates access to historical electronic clinical data. The clinical data of the patients were collected in the Case Report Form (CRF) specific to the study. Each CRF was encrypted protecting the identity of the patient. Only the research team and the health authorities, who have a duty to maintain confidentiality, will have access to all the data collected for the study. Only information that cannot be identified may be transmitted to third parties. Once the study is finished, the data will be destroyed. The treatment, communication, and transfer of data were done in accordance with the provisions of the General Data Protection Regulation (Regulation (EU) 2016/679 of the European Parliament and of the Council, of April 27, 2016). The data collected were used for the purposes of the research study described in the protocol and kept for the time necessary to achieve the objectives of the study and in accordance with applicable legislation. Research Ethics Committee Santiago-Lugo has approved this study and has set the conditions for sharing the data used in its development. As this is a retrospective study of medical records and archived samples that does not deviate from routine clinical practice, the Ethics Committee considers that patient informed consent and fully anonymization of the data before being access are enough requirements to carry out the study.

: Not applicable.

: The authors declare no competing interests.