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Any protocol amendments will be submitted to King\u2019s College REC for approval. The trial will comply with good clinical practice guidelines over the reporting of adverse events (AEs), serious adverse events (SAEs), and suspected serious adverse reactions (SUSARs) as well as providing the REC with progress reports and final study report.Patient or participant protocol involvementThere was no patient or participant involvement in the study protocol design.Protocol amendmentsIf amendments to this protocol are required, approval will be sought from the KCL-REC and updated protocol will be made available on request. This protocol version is 1.5, 10th October 2024. The PI will notify the trial sponsor, funders, and trial centre clinical teams of any protocol changes. 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