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Table 5 Comparison of distributions of the secondary continuous outcomes between the two intervention groups in each analysis set (intention-to-treat or per protocol)

From: Statistical analysis plan for the EuroHYP-1 trial: European multicentre, randomised, phase III clinical trial of the therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke

Outcome Population Intervention group Percentiles N Mean (SD) (Minimum, maximum) P of difference
25% 50% 75%
NIHSS score Range of possible scores at 91+/-14 days (RS): 0 to 42 Worst = 42 Intention-to-treat (ITT) Group 0        
Group 1       
Per protocol (PP) Group 0        
Group 1       
EQ-5D-5 L score at 91+/-14 days RS: 0 to 100 Worst = 0 ITT Group 0        
Group 1       
PP Group 0        
Group 1       
Brain infarct size at 48 +/-24 hours Worst = 1 ITT Group 0        
Group 1       
PP Group 0        
Group 1       
WHODAS 2.0 score at 91+/-14 days ITT Group 0        
Group 1       
PP Group 0        
Group 1       
  1. SD standard deviation, NIHSS National Institutes of Health Stroke Score, EQ-5D-5 L EuroQoL quality-of-life scale
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