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Both groups spent the same average time per arm.
The study will enroll approximately 360 patients (180 per arm), allowing for a 10% drop-out.
Based on the statistical design, the investigators plan to enroll 92 elderly patients, 46 per arm.
The sample size required were 220 patients (110 per arm) including the 10% dropout.
282 subjects were evaluable; 141 per arm.
The estimated sample size needed to meet these requirements was 2125 children (531 per arm).
Planned inclusion was 44 patients per arm.
The study aims to include 325 patients per arm.
To achieve this, 30 35 patients per arm were required.
This equates to 92 participants per arm of the study.
Computerised 1 1 randomisation will allocate 908 patients per arm.
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