1. Pivotal Label Comprehension Study Mevacor ™ OTC Capt. Laura Shay, RN, MS, C-ANP Division of Over-the-Counter Drug Products Center for Drug Evaluation and Research

9. Assessment of Comprehension Clinical Significance 0% 100%

12. Study Design

14. 25 sites (shopping malls) across the country

22. Results of the Unexplained Muscle Pain Scenario: 97% 79% Low Literacy 99% 79% Non-Low Literacy 99% 74% Non-Caucasian 98% 81% Caucasian 98% 79% Total Correct plus Acceptable Correct Cohorts

26. Results of the Liver Disease Scenario: 100 % 65 % Low Literacy 99 % 70 % Non-Low Literacy 99 % 71 % Non-Caucasian 99 % 68 % Caucasian 99 % 69 % Total Correct plus Acceptable Correct Cohorts

27. Study Results Based on % of Correct Answers from the Total Representative Sample (answers adhered to the label)

32. % Correct Answers: False Positives Correct plus Acceptable Correct 95% 64% Constipation 95% 69% Gas from Food 94% 64% Poison Ivy 96% 72% Tums for Indigestion 98% 66% Developed a Cold

37. Summary: Clinically Significant Communication Objectives Clinical Significance 0% 100% 20% 40% 80% 60% breast feeding (77%) unexplained muscle pain (79%) explained muscle pain (47%) allergy to lovastatin (72%) pregnant (74%) liver disease (69%)