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Article History

Received: 16 May 2019

Accepted: 18 January 2020

First Online: 14 February 2020

Ethics approval and consent to participate

: Ethics approval has been granted by the Human Research Ethics Committee at the University of Notre Dame Australia (UNDA; approval number 018091F). All participants, including the residents and their family members, will need to consent to participate. The results gathered beyond this protocol paper will be presented for the total sample, not for individual cases, and all participants will be given a unique identification number to de-identify their information.

: The authors declare that there may be a perceived conflict of interest in undertaking research funded by MGC Pharmaceuticals, the manufacturer of the drug used in the trial; a number of precautionary steps have been implemented to minimise these. These steps include input on study design and drug doses obtained in the development of the research protocol and securing TGA approval for provision of the drug. All MGC Pharmaceuticals staff will be excluded from the trial itself, including the data collection as well as analysis and interpretation of the data. In joint management meetings, the progress of the study will only be discussed in broad terms to ensure compliance with budgetary issues and appropriate responses to any serious adverse events. UNDA has written permission from MGC Pharmaceuticals Ltd. for a worldwide, non-exclusive, royalty-free license to use the project intellectual property for non-commercial research purposes, including consent to publish research findings regardless of the results. The results will be disseminated via brief reports provided to the participating aged care facilities, as well as through manuscript publications and conference presentations.