Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}
Substantial amendments are only implemented after approval of the CEC and CA respectively.Under emergency circumstances, deviations from the protocol to protect the rights, safety, and well-being of human subjects may proceed without prior approval of the sponsor and the CEC/CA. Such deviations shall be documented and reported to the sponsor and the CEC/CA as soon as possible.All non-substantial amendments are communicated to the CA as soon as possible if applicable and to the CEC within the Annual Safety Report. In case substantial amendments are implemented and approved by CEC and CA, the trial protocol will be updated on ClinicalTrials.gov (Identifier: NCT04479397).