Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03722238
• Collaborator: (none)
• Enrollment: 613
• Locations: 27
• Arm: 1
• Actual Duration (Months): 10
• Patients Per Site: 22.7
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

This will be an open-label, multicenter, 30-day, unsupervised AUS among targeted (at-risk) adult and adolescent consumers designed to mimic an OTC-like environment. More specifically, "at-risk" consumers, as discussed with the FDA, will comprise elderly consumers (>65 years of age), consumers with an increased risk of gastrointestinal (GI) bleeding or cardiovascular (CV) adverse events, consumers who experience severe pain, low literacy subjects, and adolescents (12-17 years of age). The total number of subjects expected to enroll into the study is approximately 820. Sites will be pharmacies in diverse geographic locations around the US. Prospective adult subjects will be recruited via general population and targeted risk condition advertising (although participants will not be informed as to specific health conditions for which they are being recruited), while adolescents will be recruited using targeted, outbound pre-recruiting telephone calls. Subjects (or the parents/guardians of prospective adolescent subjects) responding to the advertisements or recruitment calls will be initially screened by telephone, and eligibility will subsequently be verified in-person at the pharmacy site.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 613 participants
• Allocation: N/A
• Intervention Model: Parallel Assignment
• Intervention Model Description: The Actual Use Trial (AUT) design utilizes a real world setting to assess the ability of consumers to use an investigational product that will be marketed in an over-the-counter setting according to the proposed product labelling. The primary objective of this AUT is to evaluate compliance with the labeled dosing directions for Advil 12 Hour and to understand why misuse occurred and if it was a conscious decision by the subject. A secondary objective is to evaluate the safety of Advil 12 Hour in unsupervised actual use and how it relates to misuse.The Actual Use Trial (AUT) design utilizes a real world setting to assess the ability of consumers to use an investigational product that will be marketed in an over-the-counter setting according to the proposed product labelling. The primary objective of this AUT is to evaluate compliance with the labeled dosing directions for Advil 12 Hour and to understand why misuse occurred and if it was a conscious decision by the subject. A secondary objective is to evaluate the safety of Advil 12 Hour in unsupervised actual use and how it relates to misuse.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: MULTICENTER ACTUAL USE AND COMPLIANCE STUDY OF IBUPROFEN 600 MG IMMEDIATE RELEASE/EXTENDED RELEASE TABLETS AMONG TARGETED (AT-RISK) CONSUMERS IN A SIMULATED OVER-THE-COUNTER ENVIRONMENT
• Actual Study Start Date: Dec 27, 2018
• Actual Primary Completion Date: Oct 28, 2019
• Actual Study Completion Date: Oct 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ibuprofen 600 mg Immediate Release/Extended Release Tablets Ibuprofen 600 mg Immediate Release/Extended Release Tablets	Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet; Ibuprofen 600 mg Immediate Release/Extended Release Tablet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period [From first purchase of study drug (Day 1) to Day 30]

   Use period was defined as 30 days from purchase.

2. Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period [From first purchase of study drug (Day 1) to Day 30]

   Use period was defined as 30 days from purchase.

3. Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period [From first purchase of study drug (Day 1) to Day 30]

   Use period was defined as 30 days from purchase.

4. Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period [From first purchase of study drug (Day 1) to Day 30]

   Use period was defined as 30 days from purchase.

Secondary Outcome Measures

1. Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period [From first purchase of study drug (Day 1) to Day 30]

   Use period was defined as 30 days from purchase.

2. Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period [From first purchase of study drug (Day 1) to Day 30]

   Use period was defined as 30 days from purchase.

3. Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period [From first purchase of study drug (Day 1) to Day 30]

   Use period was defined as 30 days from purchase.

4. Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period [From first purchase of study drug (Day 1) to Day 30]

   Use period was defined as 30 days from purchase.

5. Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse [From first purchase of study drug (Day 1) to Day 30]

   Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.

6. Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse [From first purchase of study drug (Day 1) to Day 30]

   Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.

7. Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse [From first purchase of study drug (Day 1) to Day 30]

   Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.

8. Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse [From first purchase of study drug (Day 1) to Day 30]

   Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.

9. Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions [From first purchase of study drug (Day 1) to Day 30]

10. Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions [From first purchase of study drug (Day 1) to Day 30]

11. Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions [From first purchase of study drug (Day 1) to Day 30]

12. Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions [From first purchase of study drug (Day 1) to Day 30]

13. Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions [From first purchase of study drug (Day 1) to Day 30]

14. Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions [From first purchase of study drug (Day 1) to Day 30]

15. Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions [From first purchase of study drug (Day 1) to Day 30]

16. Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions [From first purchase of study drug (Day 1) to Day 30]

17. Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days [From first purchase of study drug (Day 1) to Day 30]

    Participants did not need to necessarily use the study medication for 10 consecutive days.

18. Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days [From first purchase of study drug (Day 1) to Day 30]

    Participants did not need to necessarily use the study medication for 10 consecutive days.

19. Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days [From first purchase of study drug (Day 1) to Day 30]

    Participants did not need to necessarily use the study medication for 10 consecutive days.

20. Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days [From first purchase of study drug (Day 1) to Day 30]

    Participants did not need to necessarily use the study medication for 10 consecutive days.

21. Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days [From first purchase of study drug (Day 1) to Day 30]

    Participants did not need to necessarily use the study medication for 7 consecutive days.

22. Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days [From first purchase of study drug (Day 1) to Day 30]

    Participants did not need to necessarily use the study medication for 7 consecutive days.

23. Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days [From first purchase of study drug (Day 1) to Day 30]

    Participants did not need to necessarily use the study medication for 7 consecutive days.

24. Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days [From first purchase of study drug (Day 1) to Day 30]

    Participants did not need to necessarily use the study medication for 7 consecutive days.

25. Percentage of Participants in Data Analysis Set 1 Who Took More Than 2 Doses on a Calendar Day [From first purchase of study drug (Day 1) to Day 30]

    More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.

26. Percentage of Participants in Data Analysis Set 2 Who Took More Than 2 Doses on a Calendar Day [From first purchase of study drug (Day 1) to Day 30]

    More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.

27. Percentage of Participants in Data Analysis Set 3 Who Took More Than 2 Doses on a Calendar Day [From first purchase of study drug (Day 1) to Day 30]

    More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.

28. Percentage of Participants in Data Analysis Set 4 Who Took More Than 2 Doses on a Calendar Day [From first purchase of study drug (Day 1) to Day 30]

    More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.

29. Percentage of Participants in Data Analysis Set 1 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions [From first purchase of study drug (Day 1) to Day 30]

30. Percentage of Participants in Data Analysis Set 2 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions [From first purchase of study drug (Day 1) to Day 30]

31. Percentage of Participants in Data Analysis Set 3 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions [From first purchase of study drug (Day 1) to Day 30]

32. Percentage of Participants in Data Analysis Set 4 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions [From first purchase of study drug (Day 1) to Day 30]

33. Percentage of Participants in Data Analysis Set 1 Who Used the Product on More Than 10 Consecutive Calendar Days [From first purchase of study drug (Day 1) to Day 30]

34. Percentage of Participants in Data Analysis Set 2 Who Used the Product on More Than 10 Consecutive Calendar Days [From first purchase of study drug (Day 1) to Day 30]

35. Percentage of Participants in Data Analysis Set 3 Who Used the Product on More Than 10 Consecutive Calendar Days [From first purchase of study drug (Day 1) to Day 30]

36. Percentage of Participants in Data Analysis Set 4 Who Used the Product on More Than 10 Consecutive Calendar Days [From first purchase of study drug (Day 1) to Day 30]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

1. Male or female 18 years of age or older, has history of using oral OTC analgesics at OTC dose levels, defined as taking at least 5 doses/month on average during the past 3 months, and qualifies for inclusion in at least one risk group category, including cardiovascular, gastrointestinal bleeding, history of severe pain (≥5 episodes in last month) or >65 years of age (see Groups 1 4 in Section 3.1).

OR Male or female 12-17 years of age and has history of using oral OTC analgesics at OTC dose levels, defined as taking at least 5 doses/month on average during the past 3 months.

1. Evidence of a personally signed and dated informed consent document (ICD), and in the case of minor adolescent subjects (12-17 years of age or adolescent subjects residing in states where the age of majority is > than 18), an assent document, indicating that the subject and where applicable a legally acceptable representative/parent(s)/legal guardian has been informed of all pertinent aspects of the study.

2. Willing and able to comply with scheduled visits, treatment plan, and other study procedures.

3. Willing (or in the case of adolescent subjects, the parent/guardian is willing) and able to purchase study medication.

4. Agrees the product purchased is for subject's own use and not to be shared.

5. Willing (or in the case of adolescent subjects, the parent/guardian is willing) and able to provide contact information for follow up purposes.

Exclusion Criteria

Subjects with any of the following characteristics/conditions will not be included in the study:

1. Subject (or parent/guardian, if applicable) cannot read, speak, and/or understand English.

2. Trained or employed as a healthcare professional.

3. Subject or someone else in the household is employed by a pharmaceutical company, medical practice or hospital, pharmacy, managed care or health insurance organization or a contract research organization.

4. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or potential subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.

5. Participation in other studies involving investigational drug(s) within 6 months prior to study entry and/or during study participation.

6. Known hypersensitivity to ibuprofen, aspirin, or any other NSAIDs.

7. Subjects with the following clinical conditions which place them at excessively high risk or have ≥20% 10 year risk for atherosclerotic cardiovascular disease (ASCVD), as defined by the 2013 ACC/AHA Guidelines on the Assessment of Atherosclerotic Cardiovascular Risk, will not be included in the study: clinically established coronary heart disease; cerebrovascular disease; peripheral artery disease; abdominal aortic aneurysm; and chronic kidney disease. Subjects who have experienced a prior non fatal cardiovascular disease event (angina, heart failure, heart disease, heart attack, stroke/transient ischemic attack) or have had heart surgery or who currently have uncontrolled high blood pressure (either by self report or by measured systolic blood pressure higher than 180 mmHg or diastolic pressure higher than 120 mmHg at the time of the enrollment interview), will also be excluded from the study.

8. Subjects with concurrent or recent (within 30 days) use of anticoagulants, a prior history of complicated peptic ulcer, or a gastrointestinal bleeding event requiring hospitalization or blood transfusion.

9. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product (IP) administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

10. Pregnant female subjects; breastfeeding female subjects; and male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 28 days after the end of their 30-Day Use Phase or, for subjects who use the investigational product after Day 30, 28 days after the last recorded dose of investigational product.

11. 18 years of age or older and classified as normal literacy (REALM Test score ≥61) after the normal literacy group quotas (approximately 70% of adult subjects) are full or refuses to complete the REALM Test (note there is no corresponding literacy exclusion criterion for adolescent subjects based on REALM Teen score).

12. 18 years of age or older and classified as moderate (less frequent) oral OTC pain reliever user (<30 doses per month on average in the preceding 3 months) after the moderate user group quotas (approximately 33% of adult subjects) are full.

13. Not capable of swallowing a vitamin sized tablet.

14. Refuses to participate in required assessments (such as urine pregnancy, finger stick cholesterol or blood pressure tests, or unable or unwilling to comply with electronic diary procedures).

The following additional exclusion criteria will be applied for adolescent subjects only (12-17 years of age):

1. Has developmental or learning disabilities that, in the judgment of the parent/guardian or the investigator, would interfere with study participation.

2. Another adolescent child from the family is already enrolled into the study, or parent/guardian does not agree that only one adolescent child from the family or household will be enrolled into the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mills Pharmacy at Bluff Park	Hoover	Alabama	United States	35226
2	Community Clinical Pharmacy	Mesa	Arizona	United States	85202
3	ACACIA Apothecary and Wellness	Tucson	Arizona	United States	85704
4	Coconut Grove Pharmacy	Miami	Florida	United States	33133
5	Summerfield Pharmacy	Riverview	Florida	United States	33578
6	Huff's Drug Store	Ellijay	Georgia	United States	30540
7	Family Care Pharmacy	Highland	Illinois	United States	62249
8	Rice's Pharmacy	Beaver Dam	Kentucky	United States	42320
9	Catonsville Pharmacy	Catonsville	Maryland	United States	21228
10	Goodrich Pharmacy	Anoka	Minnesota	United States	55303
11	Kemper Corner Drug	Elk River	Minnesota	United States	55330
12	Cub Pharmacy #744	Rosemount	Minnesota	United States	55068
13	The Medicine Shoppe and Elsberry Pharmacy	Elsberry	Missouri	United States	63343
14	Albers Medical Pharmacy	Kansas City	Missouri	United States	64111
15	Countryside Pharmacy	Savannah	Missouri	United States	64485
16	Texas Road Pharmacy	Monroe	New Jersey	United States	08831
17	Dakota Pharmacy of Bismarck	Bismarck	North Dakota	United States	58501
18	Family Prescription Center	Bethlehem	Pennsylvania	United States	18015
19	RxXPress Health Mart Pharmacy	Grove City	Pennsylvania	United States	16127
20	Medical Center Compounding Pharmacy & Health Center	Cleveland	Tennessee	United States	37311
21	Buckeye Drugs	Lebanon	Tennessee	United States	37087
22	Summerwood Pharmacy and Compounding	Houston	Texas	United States	77044
23	The Medicine Shoppe #708	Sherman	Texas	United States	75092
24	BrickStreet Pharmacy	Tyler	Texas	United States	75701
25	Bountiful Drug	Bountiful	Utah	United States	84010
26	The Medicine Center	Salt Lake City	Utah	United States	84121
27	Montpelier Pharmacy, Inc.	Montpelier	Virginia	United States	23192

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Mar 6, 2019
• Statistical Analysis Plan - Jan 20, 2021

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03722238
• Other Study ID Numbers: B4371011; MARATHON AUT
• First Posted: Oct 26, 2018
• Last Update Posted: Sep 24, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ibuprofen

Study Results

Participant Flow

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age greater than or equal to (>=) 18 years at the time of enrollment with a history of using oral over-the-counter (OTC) analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 milligram (mg) immediate release/extended release (IR/ER) tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Period Title: Overall Study
STARTED	608	5
Safety Set	198	5
Actual Drug Users	179	5
COMPLETED	143	4
NOT COMPLETED	465	1

Baseline Characteristics

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users	Total
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	Total of all reporting groups
Overall Participants	198	5	203
Age (Count of Participants)
<=18 years	0 0%	5 100%	5 2.5%
Between 18 and 65 years	150 75.8%	0 0%	150 73.9%
>=65 years	48 24.2%	0 0%	48 23.6%
Sex: Female, Male (Count of Participants)
Female	137 69.2%	4 80%	141 69.5%
Male	61 30.8%	1 20%	62 30.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 5.1%	1 20%	11 5.4%
Not Hispanic or Latino	188 94.9%	4 80%	192 94.6%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period
Description	Use period was defined as 30 days from purchase.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	10.6 5.4%	0.0 0%

2. Primary Outcome

Title	Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period
Description	Use period was defined as 30 days from purchase.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the end-of-study (EOS) interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	7.8 3.9%	0.0 0%

3. Primary Outcome

Title	Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period
Description	Use period was defined as 30 days from purchase.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	7.3 3.7%	0.0 0%

4. Primary Outcome

Title	Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period
Description	Use period was defined as 30 days from purchase.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	2.8 1.4%	0.0 0%

5. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period
Description	Use period was defined as 30 days from purchase.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	22.9 11.6%	0.0 0%

6. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period
Description	Use period was defined as 30 days from purchase.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	16.2 8.2%	0.0 0%

7. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period
Description	Use period was defined as 30 days from purchase.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	14.0 7.1%	0.0 0%

8. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period
Description	Use period was defined as 30 days from purchase.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	6.1 3.1%	0.0 0%

9. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse
Description	Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	3.4 1.7%	0.0 0%

10. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse
Description	Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	2.2 1.1%	0.0 0%

11. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse
Description	Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	2.2 1.1%	0.0 0%

12. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse
Description	Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	2.2 1.1%	0.0 0%

13. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	30.7 15.5%	20.0 400%

14. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	22.3 11.3%	20.0 400%

15. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	19.0 9.6%	20.0 400%

16. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	13.4 6.8%	0.0 0%

17. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	17.9 9%	0.0 0%

18. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	14.5 7.3%	0.0 0%

19. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	13.4 6.8%	0.0 0%

20. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	7.8 3.9%	0.0 0%

21. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days
Description	Participants did not need to necessarily use the study medication for 10 consecutive days.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	1.1 0.6%	0.0 0%

22. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days
Description	Participants did not need to necessarily use the study medication for 10 consecutive days.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	1.1 0.6%	0.0 0%

23. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days
Description	Participants did not need to necessarily use the study medication for 10 consecutive days.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	1.1 0.6%	0.0 0%

24. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days
Description	Participants did not need to necessarily use the study medication for 10 consecutive days.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	0.0 0%	0.0 0%

25. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days
Description	Participants did not need to necessarily use the study medication for 7 consecutive days.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	1.1 0.6%	0.0 0%

26. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days
Description	Participants did not need to necessarily use the study medication for 7 consecutive days.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	1.1 0.6%	0.0 0%

27. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days
Description	Participants did not need to necessarily use the study medication for 7 consecutive days.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	1.1 0.6%	0.0 0%

28. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days
Description	Participants did not need to necessarily use the study medication for 7 consecutive days.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	0.6 0.3%	0.0 0%

29. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 1 Who Took More Than 2 Doses on a Calendar Day
Description	More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	11.7 5.9%	0.0 0%

30. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 2 Who Took More Than 2 Doses on a Calendar Day
Description	More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	7.8 3.9%	0.0 0%

31. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 3 Who Took More Than 2 Doses on a Calendar Day
Description	More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	7.3 3.7%	0.0 0%

32. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 4 Who Took More Than 2 Doses on a Calendar Day
Description	More than 2 doses on a calendar day means more than 2 dosing occasions on a calendar day.
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	2.8 1.4%	0.0 0%

33. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 1 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Re-dosed in <12 Hours	47.5 24%	0.0 0%
Re-dosed in <10 Hours	36.3 18.3%	0.0 0%
Re-dosed in <8 Hours	29.1 14.7%	0.0 0%

34. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 2 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Re-dosed in <12 Hours	43.0 21.7%	0.0 0%
Re-dosed in <10 Hours	28.5 14.4%	0.0 0%
Re-dosed in <8 Hours	19.6 9.9%	0.0 0%

35. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 3 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Re-dosed in <12 Hours	42.5 21.5%	0.0 0%
Re-dosed in <10 Hours	26.8 13.5%	0.0 0%
Re-dosed in <8 Hours	17.3 8.7%	0.0 0%

36. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 4 Who Re-dosed in Less Than (<)12 Hours, <10 Hours and <8 Hours on 1 or More Occasions
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of drug and recorded in electronic diary. Data analysis set 4 included set 3 plus pre-specified mitigation factors (healthcare practitioner consultation, participants indicated: they would have taken opioid or other prescribed analgesic if not taken another dose, misuse of acetaminophen or other OTC analgesics and re-dosed earlier due to scheduling restrictions to prevent pain from returning) resulting in reclassification of misuses to acceptable status.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Re-dosed in <12 Hours	39.7 20.1%	0.0 0%
Re-dosed in <10 Hours	18.4 9.3%	0.0 0%
Re-dosed in <8 Hours	12.3 6.2%	0.0 0%

37. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 1 Who Used the Product on More Than 10 Consecutive Calendar Days
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 1 included the original data exactly as recorded by participants into their electronic diary.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	22.3 11.3%	0.0 0%

38. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 2 Who Used the Product on More Than 10 Consecutive Calendar Days
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 2 included the data clarified by the nurses during the EOS interview under very specific pre-specified conditions when participants spontaneously identified dosing occasion specific entry errors in their original electronic diary data.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	22.9 11.6%	0.0 0%

39. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 3 Who Used the Product on More Than 10 Consecutive Calendar Days
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Participants who took at least 1 dose of study medication and recorded it in the electronic diary. Data analysis set 3 included the corrected/mitigated data that comprised of data analysis set 2 and misuses mitigated for additional diary entries judged to be incorrect or impossible based on participant's clear verbatim responses in the EOS interview.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	179	5
Number (95% Confidence Interval) [Percentage of participants]	22.9 11.6%	0.0 0%

40. Secondary Outcome

Title	Percentage of Participants in Data Analysis Set 4 Who Used the Product on More Than 10 Consecutive Calendar Days
Time Frame	From first purchase of study drug (Day 1) to Day 30

Outcome Measure Data

Analysis Population Description

Data for this outcome measure was not estimable based on the pre-specified mitigation factors, as consecutive use days were not dosing errors and therefore not mitigable. Hence, no results were calculated.

Arm/Group Title	Adult Compliance-Evaluable Population	Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.	The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
Measure Participants	0	0

Adverse Events

Time Frame	First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days)
Adverse Event Reporting Description	Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set included all the participants who signed informed consent and purchased the product.
Arm/Group Title	Adult Compliance-Evaluable Population		Adolescent Users
Arm/Group Description	The participants included in this group were male or female of age >=18 years at the time of enrollment with a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months. Also, these participants had at least one of the following condition among cardiovascular risk, gastrointestinal bleeding risk, history of severe pain (>=5 episodes in last month) or >65 years of age. Participants were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.		The participants were male or female with age between 12 to 17 years at the time of enrollment who had a history of using oral OTC analgesics at a dose levels of taking at least 5 doses per month on average during the past 3 months were observed for the appropriate use of orally administered ibuprofen 600 mg IR/ER tablets and compliance with the dosing instructions of total daily dose =1200 mg throughout the 30 days use.
All Cause Mortality
	Adult Compliance-Evaluable Population		Adolescent Users
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/198 (0.5%)		0/5 (0%)
Serious Adverse Events
	Adult Compliance-Evaluable Population		Adolescent Users
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/198 (2%)		0/5 (0%)
Gastrointestinal disorders
Pancreatitis acute	1/198 (0.5%)		0/5 (0%)
General disorders
Death	1/198 (0.5%)		0/5 (0%)
Metabolism and nutrition disorders
Hypoglycaemia	1/198 (0.5%)		0/5 (0%)
Psychiatric disorders
Depression	1/198 (0.5%)		0/5 (0%)
Social circumstances
Victim of crime	1/198 (0.5%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Adult Compliance-Evaluable Population		Adolescent Users
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/198 (4.5%)		1/5 (20%)
Gastrointestinal disorders
Nausea	4/198 (2%)		1/5 (20%)
Infections and infestations
Nasopharyngitis	5/198 (2.5%)		0/5 (0%)

Limitations/Caveats

This study was terminated early due to recruitment problems and challenges. No safety concerns led to the decision to terminate.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.