Registration and randomization

♦ Give clear instructions for the procedure for registering or randomizing patients.

♦ For randomized trials we suggest including at the end of this section a standard statement such as the following, to remind collaborators of the implications of randomizing patients into the trial.

'This trial is a comparison of treatment policies. Once a patient has been randomized, that patient remains in the trial and all report forms are required. If the patient decides to withdraw from treatment, report forms should continue to be sent giving such information as is available on the patient's progress.'

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