Protocol and statistical analysis plan for the TREATT trial

Abstract

This document was constructed using the National Health Service Blood and Transplant Clinical Trials Unit (NHSBT CTU) Protocol Template, and incorporates the SPIRIT guidelines 2013 (1, 2). It describes the TREATT trial, coordinated by the NHSBT CTU, and provides information about procedures for entering patients/participants into it. The protocol should not be used as an aide-memoire or guide for the treatment of other patients. Every care has been taken in drafting this protocol, but corrections or amendments may be necessary. These will be circulated to the registered investigators in the trial, but sites entering participants for the first time are advised to contact the Trial Manager to confirm they have the most up to date version

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