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2.7. Randomization, allocation concealment, and blinding
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In order to randomize the participants, a computer random number generator was used so that the participants received one of the vitamins B6 or placebo in equal and one to one ratio in blocks of four. The drugs were concealed using numbered packages. Randomization and assignment were done by a person who had no involvement in the study. None of the participants in the study knew how the drugs were allocated. This included physicians, nurses, patients, statisticians, and investigators who rated the patients and prescribed drugs.
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