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Table 4 Comparison of the distributions of the secondary binary outcomes between the two intervention groups in each analysis set (intention-to-treat and 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

Population

Intervention group

Outcomes

Death

mRS > 2

N (%)

Relative risk (RR) (95% CI)

P

N (%)

RR (95% CI)

P

Intention-to-treat (ITT)

Group 0

      

Group 1

  

Per protocol (PP)

Group 0

      

Group 1

  
  1. mRS modified Rankin score, CI confidence interval