Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ibuprofen caplet · 1 trial · 1 indication
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants took more than 1200 mg (\>3 caplets) on either 0, 1 or 2 use days (where a use day was defined as a calendar day starting at 12:01 AM in which a participant received at least one dose of study medication), based on their diary. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking more than 3 caplets per day, under the advice of a healthcare professional, based on information from the end of study follow-up interview.
| Arm | Type | Description |
|---|---|---|
| Ibuprofen caplet arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Ibuprofen 400 mg caplet | DRUG | 400 milligram (mg) caplet according to Drug Facts label |
Inclusion Criteria: * Male or female at least 18 years of age (19 years of age in Alabama) * Subject reports taking over-the-counter (OTC) analgesics for pain or fever relief Exclusion Criteria: * Current government-issued identification (ID) * Pregnant or breastfeeding females