Naproxen Sodium Extended-Release Actual Use Study

• Use Days With One or More Misuse Occasions [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.
  
  

• Dosing Occasions With One and More Than One Tablet Taken [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.
  
  
• Use Days With and Without Next Dose Less Than 22 Hours Later [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in one use-day. If a subject reported product consumption on three different days this resulted in three use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.
  
  
• Number of Subjects With and Without More Than One Tablet Taken Per Dose [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  
• Number of Subjects With and Without Next Dose Less Than 22 Hours Later [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  This Outcome is a measure of subjects while Outcome Measure 3 provides the outcome as a measure of cumulative number of use-days for all subjects involved.
  
  
• Number of Subjects With and Without More Than 660 mg at Least Once [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  This measure refers to number of subjects that exceeded 660 mg of naproxen sodium per day at least once during the reporting period. The maximum dose (660 mg) may have been exceeded with one dose (if a subject consumed two tablets in one dosing occasion) or may have been exceeded throughout the course of a use-day (if a subject took one tablet in one dosing occasion and then later in the same day took one or more tablets in another dosing occasion).
  
  
• Average Daily Dose [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  
• Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing
  
  
• Number of Total Dosing Occasions Per Subject [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.
  
  
• Number of Dosing Occasions Per Subject That Exceeded 660 mg [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.
  
  

Issues on adverse event data are addressed in the Adverse Event section.

The following acronyms and abbreviations were used in the results section.

- General Educational Development (GED)