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Figure 2 Enrollment and Randomization
This double-masked, randomized trial, designed to study the effects of a dietary intervention on vascular function in diabetic patients, consisted of a feasibility study and a consecutive efficacy study. Ten patients were randomized into the feasibility study. For the efficacy study, 44 patients were assigned to either the control or the treatment group, receiving a cumulative daily dose of flavanols of 75 mg (control group) and 963 mg (treatment group), respectively.