In Reply Dr Perner and colleagues suggest that allocation concealment was not ensured in the CRISTAL trial. However, procedures were in place to hide the allocation sequence until assignment. Sequentially numbered, sealed, and opaque envelopes were used. An envelope assigned to a patient was opened only after the investigator wrote patient information on it. The signed inclusion sheet with patient and randomization details was faxed to the coordinating center, allowing monitoring of treatment allocation to unique patients in appropriate order. Only 6 errors in envelope assignment were found, corresponding to simultaneous inclusion of a patient by multiple investigators in the same center. This process ensured a low risk of bias.1
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