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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