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Article History

Received: 7 February 2026

Accepted: 4 August 2026

First Online: 28 August 2026

Declarations

Ethics approval and consent to participate: The study has been designed and will be conducted in accordance with Declaration of Helsinki with participants’ safety and health to be our utmost priority. The study obtained ethical approval from the Clinical Research Ethics Committee of the Cork Teaching Hospitals (CREC), Cork, Ireland, reference number: ECM 4 (x) 10/09/2024 and ECM 5 (7) 10/09/2024 on 4th March 2025. The current protocol version v1.5 is amended and accepted by the ethics committee. Any future revisions pertaining to the study procedures which affect the participants will be sent to the ethics committee for review (CREC) and communicated to the relevant study-related institutions such as trial registries, Office of Corporate and Legal Affairs and quality regulation committee under the Clinical Research Facility (CRF), UCC. Before any study-related communications, written, informed consent to participate will be obtained from all the participants.

Consent for publication: Written, informed consent to participate will be obtained from all participants. All participants in the study will be over the age of 18 years. The aspect of biological data collection and processing has been incorporated into the consent process and forms. Providing biological data is voluntary and patients will not be separately informed regarding any insights of their biological data. Should an ancillary study be developed, the project’s Informed Consent Form includes a provision whereby participants’ permission will be sought to be contacted in relation to any associated studies arising from data generated during the primary trial.

Competing interests: The authors declare no competing interests.