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Article History

Received: 15 July 2025

Accepted: 23 January 2026

First Online: 3 February 2026

Declarations

:

: This study was approved by Central Health and Disability Ethics Committee (HDEC reference: 2021 EXP 11490). National Standing Committee on Therapeutic Trials (SCOTT ) approval was obtained (21/SCOTT/118), as required for all clinical trials investigating a new medicine under New Zealand legislation [ ]. Electronic written informed consent to participate was obtained from all participants. Conduct of the study was in accordance with guidelines and regulations set forth by HDEC and SCOTT.Ethics approval was obtained from Central Health and Disability Ethics Committee on 3rd December 2021 (reference: 2021 EXP 11490. The Standing Committee on Therapeutic Trails (SCOTT) granted study approval on 20th September 2021 (reference: 21/SCOTT/118)

: Not applicable.

: SH is the inventor of ECMT-154 (as described in International Publication Number WO2022/234340 A1) and a shareholder of Manuka Bioscience. SH was also a contractor (R&D Strategist) at Manuka Bioscience. SH had input into protocol development but was not involved in study conduct or data analysis. AS and GS declare funding from Manuka Bioscience to the MRINZ for the submitted work. There are no other conflicts of interest to declare.