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Layout: \ n \ nDouble-blind randomized trial \ n \ nRandomization: \ n \ nSimple Randomization generated by an on-line randomizer \ n \ nSample Size: \ n \ nDifference between two ways of main outcome where \ n \ nmean distinction = 0. 05 \ npool difference = 0. 09 \ nZ 1-α/ 2 = 1. 95 with type 1 mistake 5% \ n1-β = 1. 282 with power 90%.
Source link: https://clinicaltrials.gov/ct2/show/NCT04557943
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