Naproxen Sodium Extended-Release Actual Use Study

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)

Inclusion Criteria:

- Self report use of Over The Counter (OTC) analgesics

- Able to read and understand English

- Provide written informed consent (subjects 12- 17 years of age provide written as
sent and/ or parent or legal guardian provide written consent)

- Purchase the investigational product

Exclusion Criteria:

- Have participated in a study involving OTC analgesics in the last 12 months

- They or someone else in the household work for a market research company, an
advertising agency, a public relations firm, pharmaceutical company, as a healthcare
professional, or as part of a health care practice

- Have a history of known allergies to nonsteroidal anti-inflammatory drugs (NSAIDs)
(i.e., Naproxen, Ibuprofen, etc) or Aspirin

- Have a history of heart surgery in the last 60 days or plans for heart surgery in the
next 60 days

- (Female subjects) are pregnant or breastfeeding