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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
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