Table Five. Exclusions due to age, NIHSS, time, and use of IAT before and after the protocol amendment.

The criteria for both inclusion and exclusion changed with the protocol amendment, so the selection of patients for screening and for enrollment changed. There were dramatic decreases in the proportion of patients excluded for age, NIHSS, and time to presentation, which reflect the amended selection criteria. In addition, prior to the amendment 78 patients were excluded from the trial because they underwent IAT, a criterion that did not exist after the amendment. Enrollment increased dramatically from 1.3 to 6.2% of screened patients after the amendment. Due to the asymmetric sample sizes, and the fact that both screening and enrollment criteria changed, a statistical test of significance is not appropriate, but for illustration purposes only, the Fisher’s Exact Test Odds Ratio [95%CL] for increased enrollment is 4.9 [2.3,10.4], with p<0.001.

Selection Variable	Patients Excluded Before Protocol Amendment (% of Total Screened)	Patients Excluded After Protocol Amendment (% of Total Screened)
Age	130 (21.9)	29 (3.8)
NIHSS	270 (45.5)	162 (21.3)
Late (3 hours before; 6 hours after)	75 (12.6)	27 (3.6)
No. excluded for IAT	78 (13.1)	N/A
Total Enrolled and Treated	8 (1.3)	51 (6.2)
Total Screened	601	821