Pierce, Doris http://orcid.org/0000-0002-4593-1218
Merone, Lea
Lewis, Chris
Rahman, Tony
Croese, John
Loukas, Alex
McDonald, Malcolm
Giacomin, Paul
McDermott, Robyn
Funding for this research was provided by:
AITHM (NA)
Far North Queensland Hospital Foundation (NA)
Article History
Received: 15 January 2019
Accepted: 26 November 2019
First Online: 11 December 2019
Ethics approval and consent to participate
: The study (Trial Protocol Version 5.0 dated 03/04/2018) was approved by JCU’s Human Research Ethics Committee (Approval number C26) and trial conduct will be subject to the sponsor’s (JCU) Research Governance. Important protocol modifications will be communicated to all investigators, JCU’s Human Ethics Research Committee, and trial registries. Should these modifications impact on already recruited participants, renewed informed consent will be obtained, as required.Prior to any eligibility assessment, the study doctor will obtain written informed consent from potential participants after all open questions have been clarified, and the volunteer agrees to participate. Participants can withdraw from the trial at any time without providing reasons. In case of withdrawal, participants will be scheduled for an Early Termination Visit for final health assessments. Data collected prior to and during the Early Termination Visit will form part of the study results (identification number removed).The study is not expected to involve any substantial risk or cost to the participants; therefore, volunteers will not receive financial compensation for participation in this trial. However, participants will be reimbursed for the cost of any reasonable travel or parking cost associated with the study visits.The study doctors, nurses and scientists will receive no payment from the Sponsor or their institutions for undertaking this research study (other than their ordinary wages). No member of the research team will receive a personal financial benefit from involvement in this study (other than their ordinary wages).
: Not applicable.
: The authors currently have no competing interests to declare.