Conclusion

1. Conclusion Manfred Haehl, MD Senior Vice President Medical & Drug Regulatory AffairsBoehringer Ingelheim Pharmaceuticals, Inc.Ridgefield, Connecticut

2. AGGRENOX™Conclusion • AGGRENOX™ represents a therapeutic advance to the secondary prevention of stroke that builds on the clinical experience with its components • The findings both ex vivo and in vivo are consistent with additive beneficial effects of aspirin and dipyridamole

3. AGGRENOX™Conclusion • ESPS-2 provides compelling evidence of the safety and efficacy of AGGRENOX™ that can be generalized to clinical practice • ESPS-2 is robust and eliminates concerns regarding chance or bias as the basis for the findings • ESPS-2 meets the requirements for a single trial to support approvability

4. AGGRENOX™Conclusion • The factorial and pairwise comparisons support the conclusion that in the secondary prevention of stroke • AGGRENOX™ • is significantly superior to aspirin or extended release dipyridamole alone and • has a favorable benefit-risk ratio

5. AGGRENOX™Conclusion • AGGRENOXTM:59 stroke events prevented per 1000 patients treated for 2 years vs • ASA: 30 events prevented per 1000 patients treated for 2 years vs • DP-ER: 26 events prevented per 1000 patients treated for 2 years

6. AGGRENOX™Conclusion • Based on the positive trend for a mortality benefit consistent with the aspirin label and the inclusion of an FDA-approved daily dose of aspirin, • it is appropriate from a scientific and regulatory perspective to afford AGGRENOXTM the same label indication as aspirin

7. AGGRENOX™Conclusion • ESPS-2 establishes AGGRENOXTM as firstline therapy for secondary prevention of stroke and its labeling should describe its superiorityto aspirin

8. Conclusion Manfred Haehl, MD Senior Vice President Medical & Drug Regulatory AffairsBoehringer Ingelheim Pharmaceuticals, Inc.Ridgefield, Connecticut