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Table 3 Estimated sample size considering dropout rate

From: Efficacy and safety of Lenzumestrocel (Neuronata-R® inj.) in patients with amyotrophic lateral sclerosis (ALSUMMIT study): study protocol for a multicentre, randomized, double-blind, parallel-group, sham procedure-controlled, phase III trial

 

Study Group 1

Study Group 2

Control group

Total No. of subjects

Cases for efficacy evaluation

19

32

32

83

Cases including dropouts (approximately 15%)

23

46

46

115