Ethics and dissemination
All contributing studies and the meta-trial will be performed in
accordance with the ethical principles of the Declaration of Helsinki.
Approval of the protocols and related documents will be obtained from
the relevant Human Research Ethics Committee (HREC) or Institutional
Review Board (IRB) prior to the commencement of each individual study.
These authorisations will include data inclusion in the meta-analysis.
The investigators of the individual studies will ensure that all
HREC/IRB conditions for the conduct of each study are met and that all
requisite information is submitted to the responsible HREC/IRB. Any
protocol modifications will be communicated timely to relevant parties,
including investigators and HREC/IRBs.
Patients will be asked for their consent to participate in the trial.
The results of this study will be provided to the WHO, published in
peer-reviewed medical journals and presented to the medical community
and other stakeholders.