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Analysis of mRS responders was a prespecified secondary analysis, with 'responders' defined as mRS at 3 months = 0 if NIHSS score at baseline was 4-7, mRS at 3 months = 0-1 if NIHSS score at baseline was 8-14, and mRS at 3 months = 0, 1, or 2 if NIHSS score at baseline was 15-22. Analysis of mRS responders was a prespecified secondary analysis, with 'responders' defined as mRS at 3 months = 0 if NIHSS score at baseline was 4-7, mRS at 3 months = 0-1 if NIHSS score at baseline was 8-14, and mRS at 3 months = 0, 1, or 2 if NIHSS score at baseline was 15-22. The pre-specified, primary outcome measurement of the trial was the comparison of the percentages of patients treated with citicoline or placebo who achieved at least a 7-point improvement on NIHSS (National Institutes of Health Stroke Scale) scores from enrollment through the combined 12-week treatment and follow-up period. |
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