[Fanele]

Thank you for the question, if the protocol is sent to site, it gets reviewed by the CAB first. Broader stakeholders get a chance of reviewing it as a matter of information. The targeted population gets to have a view on the protocol, and their comments and recommendations are solicited to the final version. This happens through representatives of the population. The protocol and informed consents are reviewed separately, to get opinions especially on informed consents. It is much easier to review consent forms separately because if they are in the protocol, it is not very practical to exhaust the documents.