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The Clinical Trial Service Unit (CTSU) at Oxford University is coordinating this study and will have overall responsibility for the administration and coordination of the study. There is a Steering Committee to oversee the trial conduct. The CTSU will be responsible for the training and monitoring of all staff directly involved in the study; for the supply of packaged study drugs and other study materials; for the identification (with the assistance of the local medical collaborators) of potentially eligible participants; for obtaining any relevant permissions to invite suitable patients to participate; for the initial invitation of participants and subsequent randomisation and follow-up by mail; for the provision of a 24-hour Freefone telephone service; and for the collection and analysis of data, and blood and urine samples.