Trial Outcomes & Findings for Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers (NCT NCT03722238)

NCT ID: NCT03722238

Last Updated: 2021-09-24

Results Overview

Use period was defined as 30 days from purchase.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 613 participants
• Primary outcome timeframe: From first purchase of study drug (Day 1) to Day 30
• Results posted on: 2021-09-24

Participant Flow

Participant milestones

Measure	Adult Compliance-Evaluable Population 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.	Adolescent Users 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.
Overall Study STARTED	608	5
Overall Study Safety Set	198	5
Overall Study Actual Drug Users	179	5
Overall Study COMPLETED	143	4
Overall Study NOT COMPLETED	465	1

Reasons for withdrawal

Measure	Adult Compliance-Evaluable Population 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.	Adolescent Users 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.
Overall Study Protocol Violation	1	0
Overall Study Physician Decision	1	0
Overall Study Death	1	0
Overall Study Lost to Follow-up	6	0
Overall Study Partial missing data	44	1
Overall Study Withdrawal by Subject	2	0
Overall Study Other	4	0
Overall Study Not returned to sign consent, download electronic diary application or to purchase study medication	2	0
Overall Study Did not meet risk classification group criteria	90	0
Overall Study Did not sign consent	17	0
Overall Study Other eligibility criteria not met pre-consent	22	0
Overall Study Not willing to purchase study medication	142	0
Overall Study Did not qualify at re-screening and medical conditions	133	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Adult Compliance-Evaluable Population n=198 Participants 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.	Adolescent Users n=5 Participants 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 n=203 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	150 Participants n=5 Participants	0 Participants n=7 Participants	150 Participants n=5 Participants
Age, Categorical >=65 years	48 Participants n=5 Participants	0 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Female	137 Participants n=5 Participants	4 Participants n=7 Participants	141 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	1 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	1 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	188 Participants n=5 Participants	4 Participants n=7 Participants	192 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Use period was defined as 30 days from purchase.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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	0.0 Percentage of participants Interval 0.0 to 0.0	10.6 Percentage of participants Interval 6.1 to 15.1

PRIMARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Use period was defined as 30 days from purchase.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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	0.0 Percentage of participants Interval 0.0 to 0.0	7.8 Percentage of participants Interval 3.9 to 11.8

PRIMARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Use period was defined as 30 days from purchase.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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	0.0 Percentage of participants Interval 0.0 to 0.0	7.3 Percentage of participants Interval 3.5 to 11.1

PRIMARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Use period was defined as 30 days from purchase.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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	0.0 Percentage of participants Interval 0.0 to 0.0	2.8 Percentage of participants Interval 0.4 to 5.2

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Use period was defined as 30 days from purchase.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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	0.0 Percentage of participants Interval 0.0 to 0.0	22.9 Percentage of participants Interval 16.7 to 29.1

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Use period was defined as 30 days from purchase.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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	0.0 Percentage of participants Interval 0.0 to 0.0	16.2 Percentage of participants Interval 10.8 to 21.6

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Use period was defined as 30 days from purchase.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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	0.0 Percentage of participants Interval 0.0 to 0.0	14.0 Percentage of participants Interval 8.9 to 19.0

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Use period was defined as 30 days from purchase.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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	0.0 Percentage of participants Interval 0.0 to 0.0	6.1 Percentage of participants Interval 2.6 to 9.7

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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	0.0 Percentage of participants Interval 0.0 to 0.0	3.4 Percentage of participants Interval 0.7 to 6.0

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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	0.0 Percentage of participants Interval 0.0 to 0.0	2.2 Percentage of participants Interval 0.1 to 4.4

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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	0.0 Percentage of participants Interval 0.0 to 0.0	2.2 Percentage of participants Interval 0.1 to 4.4

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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	0.0 Percentage of participants Interval 0.0 to 0.0	2.2 Percentage of participants Interval 0.1 to 4.4

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions	20.0 Percentage of participants Interval 0.0 to 55.1	30.7 Percentage of participants Interval 24.0 to 37.5

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions	20.0 Percentage of participants Interval 0.0 to 55.1	22.3 Percentage of participants Interval 16.2 to 28.4

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions	20.0 Percentage of participants Interval 0.0 to 55.1	19.0 Percentage of participants Interval 13.2 to 24.7

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 1 or More Occasions	0.0 Percentage of participants Interval 0.0 to 0.0	13.4 Percentage of participants Interval 8.4 to 18.4

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions	0.0 Percentage of participants Interval 0.0 to 0.0	17.9 Percentage of participants Interval 12.3 to 23.5

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions	0.0 Percentage of participants Interval 0.0 to 0.0	14.5 Percentage of participants Interval 9.4 to 19.7

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions	0.0 Percentage of participants Interval 0.0 to 0.0	13.4 Percentage of participants Interval 8.4 to 18.4

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Amount Per Dose of 600 mg on 2 or More Occasions	0.0 Percentage of participants Interval 0.0 to 0.0	7.8 Percentage of participants Interval 3.9 to 11.8

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days	0.0 Percentage of participants Interval 0.0 to 0.0	1.1 Percentage of participants Interval 0.0 to 2.7

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days	0.0 Percentage of participants Interval 0.0 to 0.0	1.1 Percentage of participants Interval 0.0 to 2.7

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days	0.0 Percentage of participants Interval 0.0 to 0.0	1.1 Percentage of participants Interval 0.0 to 2.7

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 10 or More Calendar Days	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days	0.0 Percentage of participants Interval 0.0 to 0.0	1.1 Percentage of participants Interval 0.0 to 2.7

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days	0.0 Percentage of participants Interval 0.0 to 0.0	1.1 Percentage of participants Interval 0.0 to 2.7

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days	0.0 Percentage of participants Interval 0.0 to 0.0	1.1 Percentage of participants Interval 0.0 to 2.7

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 7 or More Calendar Days	0.0 Percentage of participants Interval 0.0 to 0.0	0.6 Percentage of participants Interval 0.0 to 1.7

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 1 Who Took More Than 2 Doses on a Calendar Day	0.0 Percentage of participants Interval 0.0 to 0.0	11.7 Percentage of participants Interval 7.0 to 16.4

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 2 Who Took More Than 2 Doses on a Calendar Day	0.0 Percentage of participants Interval 0.0 to 0.0	7.8 Percentage of participants Interval 3.9 to 11.8

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 3 Who Took More Than 2 Doses on a Calendar Day	0.0 Percentage of participants Interval 0.0 to 0.0	7.3 Percentage of participants Interval 3.5 to 11.1

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

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

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 4 Who Took More Than 2 Doses on a Calendar Day	0.0 Percentage of participants Interval 0.0 to 0.0	2.8 Percentage of participants Interval 0.4 to 5.2

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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 Re-dosed in <12 Hours	0.0 Percentage of participants Interval 0.0 to 0.0	47.5 Percentage of participants Interval 40.2 to 54.8
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 Re-dosed in <10 Hours	0.0 Percentage of participants Interval 0.0 to 0.0	36.3 Percentage of participants Interval 29.3 to 43.4
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 Re-dosed in <8 Hours	0.0 Percentage of participants Interval 0.0 to 0.0	29.1 Percentage of participants Interval 22.4 to 35.7

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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 Re-dosed in <12 Hours	0.0 Percentage of participants Interval 0.0 to 0.0	43.0 Percentage of participants Interval 35.8 to 50.3
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 Re-dosed in <10 Hours	0.0 Percentage of participants Interval 0.0 to 0.0	28.5 Percentage of participants Interval 21.9 to 35.1
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 Re-dosed in <8 Hours	0.0 Percentage of participants Interval 0.0 to 0.0	19.6 Percentage of participants Interval 13.7 to 25.4

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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 Re-dosed in <12 Hours	0.0 Percentage of participants Interval 0.0 to 0.0	42.5 Percentage of participants Interval 35.2 to 49.7
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 Re-dosed in <10 Hours	0.0 Percentage of participants Interval 0.0 to 0.0	26.8 Percentage of participants Interval 20.3 to 33.3
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 Re-dosed in <8 Hours	0.0 Percentage of participants Interval 0.0 to 0.0	17.3 Percentage of participants Interval 11.8 to 22.9

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
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 Re-dosed in <12 Hours	0.0 Percentage of participants Interval 0.0 to 0.0	39.7 Percentage of participants Interval 32.5 to 46.8
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 Re-dosed in <10 Hours	0.0 Percentage of participants Interval 0.0 to 0.0	18.4 Percentage of participants Interval 12.8 to 24.1
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 Re-dosed in <8 Hours	0.0 Percentage of participants Interval 0.0 to 0.0	12.3 Percentage of participants Interval 7.5 to 17.1

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 1 Who Used the Product on More Than 10 Consecutive Calendar Days	0.0 Percentage of participants Interval 0.0 to 0.0	22.3 Percentage of participants Interval 16.2 to 28.4

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 2 Who Used the Product on More Than 10 Consecutive Calendar Days	0.0 Percentage of participants Interval 0.0 to 0.0	22.9 Percentage of participants Interval 16.7 to 29.1

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Measure	Adolescent Users n=5 Participants 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.	Adult Compliance-Evaluable Population n=179 Participants 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.
Percentage of Participants in Data Analysis Set 3 Who Used the Product on More Than 10 Consecutive Calendar Days	0.0 Percentage of participants Interval 0.0 to 0.0	22.9 Percentage of participants Interval 16.7 to 29.1

SECONDARY outcome

Timeframe: From first purchase of study drug (Day 1) to Day 30

Population: 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.

Outcome measures

Outcome data not reported

Adverse Events

Adult Compliance-Evaluable Population

Serious events: 4 serious events

Other events: 9 other events

Deaths: 1 deaths

Adolescent Users

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adult Compliance-Evaluable Population n=198 participants at risk 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.	Adolescent Users n=5 participants at risk 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.
Social circumstances Victim of crime	0.51% 1/198 • First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days) 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.	0.00% 0/5 • First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days) 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.
Gastrointestinal disorders Pancreatitis acute	0.51% 1/198 • First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days) 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.	0.00% 0/5 • First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days) 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.
Psychiatric disorders Depression	0.51% 1/198 • First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days) 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.	0.00% 0/5 • First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days) 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.
Metabolism and nutrition disorders Hypoglycaemia	0.51% 1/198 • First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days) 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.	0.00% 0/5 • First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days) 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.
General disorders Death	0.51% 1/198 • First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days) 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.	0.00% 0/5 • First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days) 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.

Other adverse events

Measure	Adult Compliance-Evaluable Population n=198 participants at risk 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.	Adolescent Users n=5 participants at risk 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.
Infections and infestations Nasopharyngitis	2.5% 5/198 • First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days) 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.	0.00% 0/5 • First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days) 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.
Gastrointestinal disorders Nausea	2.0% 4/198 • First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days) 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.	20.0% 1/5 • First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days) 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.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER