Details of a prospective protocol for a collaborative meta-analysis of individual participant data from all randomized trials of intravenous rt-PA vs. control: statistical analysis plan for the Stroke Thrombolysis Trialists' Collaborative meta-analysis.

The effect of allocation to rt-PA on stroke outcome in patients ≤80 and >80 years of age will also be estimated (again, adjusted for other baseline covariates and treatment modifying effects of those covariates) and, if evidence of independent effect modification by age is observed, a test for difference in the two log-odds ratios will be performed (by comparing the difference in log odds ratios divided by its standard error against a standard normal distribution, a test that will be deemed nominally significant if the two-sided P -value is less than 0·05).

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