Figure 1From: Protocol for MInimizing the Risk of Metachronous Adenomas of the CoLorectum with Green Tea Extract (MIRACLE): a randomised controlled trial of green tea extract versus placebo for nutriprevention of metachronous colon adenomas in the elderly population Flow Diagram of the progress through the phases of the study. Assuming a drop-out rate of 5% of patients for the control colonoscopy, 1267 randomized patients per arm will be required, resulting in randomization of 2534 patients after the run-in period. 1203 patients per arm are expected to be available for the ITT analysis undergoing control colonoscopy after three years. A drop-out rate of 20% is assumed for regular capsule intake. Thus, 1014 patients will be evaluable for the per-protocol analysis of the green tea effect.Back to article page