Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
Major amendments to the protocol need the approval of the local ethics committee before they can be implemented. This especially concerns modifications that may affect the safety or risk exposure of trial participants. Upon approval, necessary protocol amendments will be communicated to all parties, including the participants. Minor changes such as organizational aspects of the study conduct do not need ethical committee approval but will be listed in the yearly safety report.All study documents are version controlled and follow track change guidelines.