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A total of 6300 subjects will be randomized to each group with the expectation that a total of 1642 primary endpoints will occur during a 5-year period, providing 90% power to detect the 15% relative reduction in events (α = 0.05) hypothesized to favor the amlodipine besylate/benazapril group.
60 patients will be randomized to each group.
According to the sample size calculation, 155 patients need to be randomized to each treatment arm.
Based on the chosen precision for A1C and an expected dropout ratio of 17%, 60 participants were to be randomized to each treatment arm.
Assuming a 25% dropout rate of patient-caregiver dyads, the study needed a final enrolment of 190 dyads in each group, so that at least 48 professionals needed to be randomized to each group.
Therefore, to adequately ensure that we have sufficient subject numbers at the end of the intervention, 65 subjects will be randomized to each of the three groups (N = 195).
Similar(52)
Nineteen patients were randomized to each group.
Eighty patients were randomized to each group.
Twelve patients were randomized to each group.
One patient was excluded due to chronic renal failure hence 42 patients were randomized to each group.
Randomization was stratified by screening type (mammography or CRC) to ensure that comparable groups of patients are randomized to each arm.
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