Document Classification

Section Type: RESULTS

Text: In patients who took study drug without food, there was a significant difference across initial-dose groups for discontinuation due to adverse events (30 mg q. a. m. = 3. 6 %, 30 mg b. i. d. = 14. 0 %, 60 mg q. a. m. = 10. 2 % ; 30 mg q. a. m. vs. 30 mg b. i. d., p =. 008 ; 30 mg q. a. m. vs. 60 mg q. a. m., p =. 066) ; however, in patients who took study drug with food, discontinuations due to adverse events did not significantly differ (30 mg q. a. m. = 5. 4 %, 30 mg b. i. d. = 7. 5 %, 60 mg q. a. m. = 7. 4 % ; all p values >. 50).