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 pooled 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.
The individual study protocols outline the process and requirements for obtaining patients’ consent to participate in their study and as required by local laws and regulations.
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.