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Table 3 Comparison of the distributions of the modified Rankin scale (mRS) 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

Population studied

Intervention group

mRS = 0

mRS = 1

mRS = 2

mRS = 3

mRS = 4

mRS = 5

mRS = 6

Common OR

P of difference

N (%)

N (%)

N (%)

N (%)

N (%)

N (%)

N (%)

(95% CI)

(reference = group 0)

Intention-to-treat (ITT)

Group 0

         

Group 1

       

Per protocol (PP)

Group 0

         

Group 1