Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}
Substantial amendments are changes to the study that may have a significant effect on the safety or rights of the patient, the robustness of the generated data, and/or the conduct of the study. Substantial amendments will be submitted to the ethics committee for approval. After approval, changes will be communicated to the study team and the trial registry will be updated.