Trial Outcomes & Findings for A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain (NCT NCT01571362)

Results Overview

Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

410 participants

Primary outcome timeframe

Weeks 11 and 12

Results posted on

2017-04-04

Participant Flow

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Determine the Efficacy and Safety of ALO-02 Extended-Release Capsules in participants with Moderate to Severe Chronic Low Back Pain

A total of 410 participants were enrolled into the Open-Label Conversion and Titration Period and 281 participants were randomized into the Double-Blind Treatment Period, of which, 280 participants received study treatment.

Participant milestones

Participant milestones
Measure	Open ALO-02 Participants received AL0-02 extended-release capsules, orally (PO), twice daily (BID), at total daily doses of oxycodone from 20 to 160 milligrams (mg) in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.	ALO-02 To Placebo Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Open-Label Conversion + Titration Period STARTED	410	0	0
Open-Label Conversion + Titration Period COMPLETED	281	0	0
Open-Label Conversion + Titration Period NOT COMPLETED	129	0	0
Double-Blind Treatment Period STARTED	0	134	146
Double-Blind Treatment Period COMPLETED	0	81	107
Double-Blind Treatment Period NOT COMPLETED	0	53	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Open ALO-02 Participants received AL0-02 extended-release capsules, orally (PO), twice daily (BID), at total daily doses of oxycodone from 20 to 160 milligrams (mg) in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.	ALO-02 To Placebo Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Open-Label Conversion + Titration Period Withdrawal by Subject	11	0	0
Open-Label Conversion + Titration Period Protocol Violation	7	0	0
Open-Label Conversion + Titration Period Adverse Event	57	0	0
Open-Label Conversion + Titration Period Lost to Follow-up	10	0	0
Open-Label Conversion + Titration Period Does not meet entrance criteria	41	0	0
Open-Label Conversion + Titration Period Other - unspecified	3	0	0
Double-Blind Treatment Period Withdrawal by Subject	0	11	5
Double-Blind Treatment Period Protocol Violation	0	8	9
Double-Blind Treatment Period Adverse Event	0	9	14
Double-Blind Treatment Period Lost to Follow-up	0	3	6
Double-Blind Treatment Period Insufficient clinical response	0	16	4
Double-Blind Treatment Period Other - unspecified	0	6	1

Baseline Characteristics

A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open ALO-02 n=410 Participants Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
Age, Customized Between 18 and 65 years	364 Participants n=5 Participants
Age, Customized >=65 years	46 Participants n=5 Participants
Sex: Female, Male Female	233 Participants n=5 Participants
Sex: Female, Male Male	177 Participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks 11 and 12

Population: Intent-to-Treat (ITT) Population: all participants who were randomized into the Double-Blind Treatment Period and received at least 1 dose of study drug after randomization; the averaged value for each participant from the 100 imputed datasets were used. Hybrid multiple and single imputation were applied, depending on reason for discontinuation.

Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=145 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=133 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12)	0.60 Units on a Scale Standard Error 0.168	1.23 Units on a Scale Standard Error 0.179

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population; imputation using last observation carried forward (LOCF) method.

The RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain. An individual participant's score can vary from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher score indicating greater disability.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=122 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=118 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).	0.67 Units on a Scale Standard Error 0.393	0.50 Units on a Scale Standard Error 0.404

SECONDARY outcome

Timeframe: Randomization Baseline, Week 12

Population: ITT Population; percentage based on the number of participants who had non-missing values at Randomization Baseline and Week 12/early termination for each treatment. Imputation using LOCF method.

Measure represents the score at Randomization Baseline / score at Week 12 (or Early Termination) in PGA, a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor).

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=137 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=130 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Poor / Very Good	0.0 Percentage of participants	0.8 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Poor / Good	1.5 Percentage of participants	2.3 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Poor / Fair	2.2 Percentage of participants	4.6 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Poor / Poor	0.0 Percentage of participants	1.5 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Poor / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Very Poor / Very Good	0.0 Percentage of participants	0.0 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Very Poor / Good	0.0 Percentage of participants	1.5 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Very Poor / Fair	0.0 Percentage of participants	1.5 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Very Poor / Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Very Poor / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Very Good / Very Good	11.7 Percentage of participants	5.4 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Very Good / Good	2.9 Percentage of participants	6.2 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Very Good / Fair	1.5 Percentage of participants	1.5 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Very Good / Poor	0.0 Percentage of participants	0.8 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Very Good / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Good / Very Good	3.6 Percentage of participants	6.2 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Good / Good	19.7 Percentage of participants	18.5 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Good / Fair	6.6 Percentage of participants	4.6 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Good / Poor	0.7 Percentage of participants	0.0 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Good / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Fair / Very Good	0.0 Percentage of participants	3.1 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Fair / Good	21.2 Percentage of participants	17.7 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Fair / Fair	26.3 Percentage of participants	23.1 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Fair / Poor	2.2 Percentage of participants	0.8 Percentage of participants
Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). Fair / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 11 and 12

Population: ITT Population

Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 equals (=) no pain to 10 = worst possible pain. Higher scores indicate greater pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20%	62.3 percentage of participants	48.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 11 and 12

Population: ITT Population

Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30%	57.5 percentage of participants	44.0 percentage of participants

SECONDARY outcome

Timeframe: Weeks 11 and 12

Population: ITT Population

Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40%	50.7 percentage of participants	35.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 11 and 12

Population: ITT Population

Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50%	39.7 percentage of participants	29.9 percentage of participants

SECONDARY outcome

Timeframe: Screening, Week 4, 5, or 6

Population: Titration Period Safety Population: defined as all participants who received any amount of ALO-02 capsules during the Open-Label Conversion and Titration Period; imputation using the LOCF method. n=number of participants contributing to the mean for the specified parameter.

BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index Worst Pain Score (n=400)	—	-3.3 Units on a Scale Standard Deviation 2.30
Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index Least Pain Score (n=400)	—	-2.6 Units on a Scale Standard Deviation 2.33
Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index Average Pain Score (n=400)	—	-3.0 Units on a Scale Standard Deviation 2.11
Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index Pain Right Now (n=400)	—	-3.3 Units on a Scale Standard Deviation 2.41
Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index Pain Severity Index (n=400)	—	-3.1 Units on a Scale Standard Deviation 2.07
Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index Pain Interference Index (n=401)	—	-2.8 Units on a Scale Standard Deviation 2.32

SECONDARY outcome

Timeframe: Screening, Randomization Baseline

Population: ITT Population - observed cases; n=number of participants assessed for the given parameter at the specified timepoint.

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=279 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index Worst Pain Score (n=279)	—	-4.2 units on scale Standard Deviation 1.83
Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index Least Pain Score (n=279)	—	-3.4 units on scale Standard Deviation 2.04
Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index Average Pain Score (n=279)	—	-3.8 units on scale Standard Deviation 1.60
Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index Pain Right Now (n=279)	—	-4.2 units on scale Standard Deviation 1.95
Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index Pain Severity Index (n=279)	—	-3.9 units on scale Standard Deviation 1.63
Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index Pain Interference Index (n=279)	—	-3.4 units on scale Standard Deviation 2.16

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for worst pain at the specified timepoint.

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain Week 2 (n=126,135)	0.38 Units on a Scale Standard Error 0.155	1.00 Units on a Scale Standard Error 0.160
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain Week 4 (n=111,125)	0.51 Units on a Scale Standard Error 0.168	1.15 Units on a Scale Standard Error 0.179
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain Week 8 (n=89,113)	0.49 Units on a Scale Standard Error 0.180	0.86 Units on a Scale Standard Error 0.205
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain Week 12/Early Termination (ET)(n=131,138)	0.47 Units on a Scale Standard Error 0.170	1.45 Units on a Scale Standard Error 0.176

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: ITT Population - imputed values at early termination. Imputation by LOCF; n=number of participants assessed for least pain at the specified timepoint.

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain Week 2 (n=126,135)	0.34 Units on a Scale Standard Error 0.134	0.74 Units on a Scale Standard Error 0.139
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain Week 4 (n=111,125)	0.06 Units on a Scale Standard Error 0.138	0.94 Units on a Scale Standard Error 0.147
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain Week 8 (n=89,112)	0.19 Units on a Scale Standard Error 0.151	0.83 Units on a Scale Standard Error 0.171
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain Week 12/ET(n=131,138)	0.28 Units on a Scale Standard Error 0.147	1.13 Units on a Scale Standard Error 0.151

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for average pain at the specified timepoint.

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain Week 2 (n=125,135)	0.36 Units on a Scale Standard Error 0.132	1.01 Units on a Scale Standard Error 0.137
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain Week 4 (n=111,124)	0.30 Units on a Scale Standard Error 0.147	1.04 Units on a Scale Standard Error 0.156
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain Week 8 (n=88,112)	0.35 Units on a Scale Standard Error 0.157	0.99 Units on a Scale Standard Error 0.179
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain Week 12/ET (n=131,138)	0.39 Units on a Scale Standard Error 0.154	1.27 Units on a Scale Standard Error 0.159

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain right now at the specified timepoint.

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now Week 2 (n=126,135)	0.40 Units on a Scale Standard Error 0.144	1.04 Units on a Scale Standard Error 0.149
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now Week 4 (n=111,125)	0.24 Units on a Scale Standard Error 0.148	1.03 Units on a Scale Standard Error 0.157
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now Week 8 (n=88,112)	0.33 Units on a Scale Standard Error 0.176	1.04 Units on a Scale Standard Error 0.200
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now Week 12/ET (n=131,138)	0.36 Units on a Scale Standard Error 0.161	1.43 Units on a Scale Standard Error 0.166

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain severity index at the specified timepoint.

Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index Week 2 (n=125,135)	0.37 Units on a Scale Standard Error 0.131	0.95 Units on a Scale Standard Error 0.136
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index Week 4 (n=111,124)	0.28 Units on a Scale Standard Error 0.137	1.04 Units on a Scale Standard Error 0.145
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index Week 8 (n=88,112)	0.34 Units on a Scale Standard Error 0.152	0.95 Units on a Scale Standard Error 0.173
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index Week 12/ET (n=131,138)	0.38 Units on a Scale Standard Error 0.144	1.32 Units on a Scale Standard Error 0.149

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain interference index at the specified timepoint.

Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index Week 2 (n=126,135)	0.36 Units on a Scale Standard Error 0.130	0.77 Units on a Scale Standard Error 0.135
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index Week 4 (n=111,127)	0.43 Units on a Scale Standard Error 0.129	0.92 Units on a Scale Standard Error 0.139
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index Week 8 (n=89,113)	0.47 Units on a Scale Standard Error 0.148	0.64 Units on a Scale Standard Error 0.168
Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index Week 12/ET (n=131,138)	0.49 Units on a Scale Standard Error 0.145	1.14 Units on a Scale Standard Error 0.149

SECONDARY outcome

Timeframe: Weeks 2, 4, 8 and 12

Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for worst pain at the specified timepoint.

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain Week 2 (n=126,134)	-3.80 Units on a Scale Standard Error 0.181	-3.09 Units on a Scale Standard Error 0.186
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain Week 4 (n=111,124)	-3.74 Units on a Scale Standard Error 0.192	-3.01 Units on a Scale Standard Error 0.203
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain Week 8 (n=89,112)	-3.72 Units on a Scale Standard Error 0.212	-3.16 Units on a Scale Standard Error 0.238
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain Week 12/ET (n=131,137)	-3.73 Units on a Scale Standard Error 0.203	-2.63 Units on a Scale Standard Error 0.207

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for least pain at the specified timepoint.

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain Week 2 (n=126,134)	-3.05 Units on a Scale Standard Error 0.157	-2.55 Units on a Scale Standard Error 0.162
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain Week 4 (n=111,124)	-3.29 Units on a Scale Standard Error 0.162	-2.40 Units on a Scale Standard Error 0.171
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain Week 8 (n=89,111)	-3.21 Units on a Scale Standard Error 0.178	-2.44 Units on a Scale Standard Error 0.199
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain Week 12/ET (n=131,137)	-3.12 Units on a Scale Standard Error 0.171	-2.14 Units on a Scale Standard Error 0.175

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for average pain at the specified timepoint.

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain Week 2 (n=125,134)	-3.43 Units on a Scale Standard Error 0.150	-2.63 Units on a Scale Standard Error 0.154
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain Week 4 (n=111,123)	-3.55 Units on a Scale Standard Error 0.164	-2.76 Units on a Scale Standard Error 0.172
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain Week 8 (n=88,111)	-3.50 Units on a Scale Standard Error 0.182	-2.71 Units on a Scale Standard Error 0.205
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain Week 12/ET (n=131,137)	-3.43 Units on a Scale Standard Error 0.172	-2.39 Units on a Scale Standard Error 0.176

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain right now at the specified timepoint.

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now Week 2 (n=126,134)	-3.72 Units on a Scale Standard Error 0.165	-3.12 Units on a Scale Standard Error 0.170
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now Week 4 (n=111,124)	-3.82 Units on a Scale Standard Error 0.177	-3.15 Units on a Scale Standard Error 0.187
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now Week 8 (n=88,111)	-3.71 Units on a Scale Standard Error 0.206	-3.00 Units on a Scale Standard Error 0.232
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now Week 12/ET (n=131,137)	-3.74 Units on a Scale Standard Error 0.186	-2.72 Units on a Scale Standard Error 0.189

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain severity index at the specified timepoint.

Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index Week 2 (n=125,134)	-3.50 Units on a Scale Standard Error 0.152	-2.83 Units on a Scale Standard Error 0.157
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index Week 4 (n=111,123)	-3.60 Units on a Scale Standard Error 0.164	-2.83 Units on a Scale Standard Error 0.172
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index Week 8 (n=88,111)	-3.53 Units on a Scale Standard Error 0.182	-2.80 Units on a Scale Standard Error 0.205
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index Week 12/ET (n=131,137)	-3.51 Units on a Scale Standard Error 0.171	-2.47 Units on a Scale Standard Error 0.174

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain interference index at the specified timepoint.

Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index Week 2 (n=126,134)	-2.99 Units on a Scale Standard Error 0.160	-2.58 Units on a Scale Standard Error 0.164
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index Week 4 (n=111,126)	-2.99 Units on a Scale Standard Error 0.164	-2.52 Units on a Scale Standard Error 0.175
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index Week 8 (n=89,112)	-2.87 Units on a Scale Standard Error 0.176	-2.72 Units on a Scale Standard Error 0.198
Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index Week 12/ET (n=131,137)	-2.88 Units on a Scale Standard Error 0.172	-2.24 Units on a Scale Standard Error 0.176

SECONDARY outcome

Timeframe: Randomization Baseline, Weeks 11 and 12

Population: ITT Population; linear interpolation was used for internal missing values, with addition of 0 to the AUC for missing values from early discontinuation.

NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). AUC was calculated using daily change from Baseline scores from Baseline until the last dose date in the Double-Blind Treatment Period. AUC was calculated for each participant using the linear trapezoidal method. Higher scores indicate greater pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12)	11.25 Change in units on a scale*days Standard Error 7.636	39.00 Change in units on a scale*days Standard Error 7.914

SECONDARY outcome

Timeframe: Daily from Day 1 of the Double-Blind Period through Week 12

Population: ITT Population

The amount of acetaminophen administered for each treatment during the Double-Blind Treatment Period. Average daily use calculated as: total dose of rescue medication during Double-Blind Period divided by the number of days in Double-Blind Period.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period	203.97 Average mg/day Standard Error 34.851	207.84 Average mg/day Standard Error 36.436

SECONDARY outcome

Timeframe: Screening, Week 4, 5 or 6

Population: Titration Period Safety Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.

The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times100.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=398 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment Participants with 40% Analgesic Response	—	67.3 Percentage of participants
Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment Participants with 50% Analgesic Response	—	49.7 Percentage of participants
Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment Participants with 20% Analgesic Response	—	85.2 Percentage of participants
Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment Participants with 30% Analgesic Response	—	78.9 Percentage of participants

SECONDARY outcome

Timeframe: Screening, Week 4, 5, or 6

Population: Titration Period Safety Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.

The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period minus (-) Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. An event was defined as a participant with 20, 30, 40, or 50% analgesic response from Screening. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the \[date of event or last diary pain score - date of first dose in Titration Period +1\].

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=398 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment Time to 20% Analgesic Response from Screening	—	15 days Interval 14.0 to 17.0
Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment Time to 30% Analgesic Response from Screening	—	21 days Interval 19.0 to 23.0
Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment Time to 40% Analgesic Response from Screening	—	28 days Interval 26.0 to 30.0
Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment Time to 50% Analgesic Response from Screening	—	35 days Interval 32.0 to 38.0

SECONDARY outcome

Timeframe: Screening, Randomization Baseline (up to 6 weeks)

Population: ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.

The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=278 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline Participants with 20% Analgesic Response	—	99.3 Percentage of participants
Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline Participants with 30% Analgesic Response	—	95.3 Percentage of participants
Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline Participants with 40% Analgesic Response	—	86.0 Percentage of participants
Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline Participants with 50% Analgesic Response	—	64.0 Percentage of participants

SECONDARY outcome

Timeframe: Screening, Randomization Baseline (up to 6 weeks)

Population: ITT Population; an event was defined as a participant with 20%, 30%, 40% or 50% analgesic response from Screening.

The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the \[date of event or last diary pain score - date of first dose in Titration Period +1\].

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=278 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline Time to 20% Analgesic Response	—	14 days Interval 13.0 to 16.0
Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline Time to 30% Analgesic Response	—	20 days Interval 17.0 to 22.0
Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline Time to 40% Analgesic Response	—	26 days Interval 23.0 to 28.0
Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline Time to 50% Analgesic Response	—	33 days Interval 30.0 to 35.0

SECONDARY outcome

Timeframe: Randomization Baseline, up to Week 12

Population: ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% loss of analgesic response from Randomization Baseline.

The percentage of lost analgesic response is defined as: (rolling 7-day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the \[date of event or last diary pain score - date of first dose in Double-Blind Treatment +1\].

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=143 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=132 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period Participants with 20% Loss of Analgesic Response	54.5 Percentage of participants	72.0 Percentage of participants
Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period Participants with 30% Loss of Analgesic Response	46.2 Percentage of participants	64.4 Percentage of participants
Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period Participants with 40% Loss of Analgesic Response	34.3 Percentage of participants	57.6 Percentage of participants
Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period Participants with 50% Loss of Analgesic Response	31.5 Percentage of participants	50.8 Percentage of participants

SECONDARY outcome

Timeframe: Randomization Baseline, up to Week 12

Population: ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% loss of analgesic response from Randomization Baseline.

The percentage of lost analgesic response was defined as: (rolling seven day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the \[date of event or last diary pain score - date of first dose in Double-Blind Treatment +1\].

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=143 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=132 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period Time to 20% Loss of Analgesic Response	31 days Interval 18.0 to Number of participants with loss of response was too low to estimate the 95% confidence interval upper limit.	12 days Interval 8.0 to 17.0
Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period Time to 30% Loss of Analgesic Response	NA days Interval 32.0 to Number of participants with loss of response was too low to estimate the median time and 95% confidence interval upper limit.	21 days Interval 15.0 to 39.0
Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period Time to 40% Loss of Analgesic Response	NA days Number of participants with loss of response was too low to estimate the median time and 95% confidence interval upper and lower limits.	41 days Interval 21.0 to 61.0
Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period Time to 50% Loss of Analgesic Response	NA days Number of participants with loss of response was too low to estimate the median time and 95% confidence interval upper and lower limits.	62 days Interval 24.0 to Number of participants with loss of response was too low to estimate the 95% confidence interval upper limit.

SECONDARY outcome

Timeframe: Week 1 up to Week 12

Population: ITT Population; an event was defined as a participant with treatment discontinuation for investigator-reported lack of efficacy.

If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy	2.7 Percentage of participants	11.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 1 up to Week 12

Population: ITT Population; an event was defined as a participant with treatment discontinuation for investigator-reported lack of efficacy.

If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. The survival duration begins on the date of first dose in the Double-Blind period and is calculated as the \[date of event or discontinuation - date of first dose in Double-Blind Period +1\].

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period	NA days Incidence of discontinuation from investigator-reported lack of efficacy was too low to estimate median.	NA days Incidence of discontinuation from investigator-reported lack of efficacy was too low to estimate median.

SECONDARY outcome

Timeframe: Screening, Weeks 1, 2, 3, 4, 5, and 6

Population: Titration Period Safety Population. Only participants with values at both Screening and each respective visit were included in the change from screening analysis; n=number of participants analyzed for the given parameter at the specified timepoint.

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Screening (n=387)	—	0.6 Units on a scale Standard Deviation 1.09
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Week 1 (n=353)	—	0.6 Units on a scale Standard Deviation 1.04
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Change from Screening at Week 1 (n=333)	—	0.0 Units on a scale Standard Deviation 1.20
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Week 2 (n=327)	—	0.5 Units on a scale Standard Deviation 1.08
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Change from Screening at Week 2 (n=308)	—	0.0 Units on a scale Standard Deviation 1.25
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Week 3 (n=316)	—	0.5 Units on a scale Standard Deviation 0.92
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Change from Screening at Week 3 (n=295)	—	-0.1 Units on a scale Standard Deviation 1.21
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Week 4 (n=210)	—	0.6 Units on a scale Standard Deviation 0.94
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Change from Screening at Week 4 (n=194)	—	0.0 Units on a scale Standard Deviation 1.27
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Week 5 (n=138)	—	0.6 Units on a scale Standard Deviation 0.82
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Change from Screening at Week 5 (n=131)	—	-0.1 Units on a scale Standard Deviation 1.15
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Week 6/ET (n=375)	—	0.6 Units on a scale Standard Deviation 0.99
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Change from Screening at Week 6 (n=352)	—	0.0 Units on a scale Standard Deviation 1.28
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Maximum Titration Period (MTP) Value (n=375)	—	1.2 Units on a scale Standard Deviation 1.42
Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period Change from screening to MTP Value (n=352)	—	0.6 Units on a scale Standard Deviation 1.54

SECONDARY outcome

Timeframe: Randomization Baseline, Weeks 1, 2, 4, 8, and 12

Population: Double-Blind Safety Population. Only participants with values at both Randomization Baseline and each respective visit were included in the change from Randomization Baseline analysis; n=number of participants analyzed for the given parameter at the specified timepoint.

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
COWS Total Score During the Double-Blind Treatment Period Randomization Baseline (n=134,146)	0.4 Units on a scale Standard Deviation 0.73	0.6 Units on a scale Standard Deviation 0.85
COWS Total Score During the Double-Blind Treatment Period Week 1 (n=111,133)	0.6 Units on a scale Standard Deviation 1.13	0.8 Units on a scale Standard Deviation 1.62
COWS Total Score During the Double-Blind Treatment Period Change from Baseline at Week 1 (n=111,133)	0.3 Units on a scale Standard Deviation 1.12	0.3 Units on a scale Standard Deviation 1.69
COWS Total Score During the Double-Blind Treatment Period Week 2 (n=115,128)	0.7 Units on a scale Standard Deviation 1.19	0.8 Units on a scale Standard Deviation 1.28
COWS Total Score During the Double-Blind Treatment Period Change from Baseline at Week 2 (n=115,128)	0.3 Units on a scale Standard Deviation 1.10	0.2 Units on a scale Standard Deviation 1.45
COWS Total Score During the Double-Blind Treatment Period Week 4 (n=106,123)	0.4 Units on a scale Standard Deviation 0.66	0.6 Units on a scale Standard Deviation 0.90
COWS Total Score During the Double-Blind Treatment Period Change from Baseline at Week 4 (n=106,123)	0.1 Units on a scale Standard Deviation 0.79	0.1 Units on a scale Standard Deviation 1.10
COWS Total Score During the Double-Blind Treatment Period Week 8 (n=87,107)	0.6 Units on a scale Standard Deviation 1.10	0.6 Units on a scale Standard Deviation 1.02
COWS Total Score During the Double-Blind Treatment Period Change from Baseline at Week 8 (n=87,107)	0.2 Units on a scale Standard Deviation 1.06	0.1 Units on a scale Standard Deviation 1.03
COWS Total Score During the Double-Blind Treatment Period Week 12/ET (n=126,140)	0.6 Units on a scale Standard Deviation 1.17	0.7 Units on a scale Standard Deviation 1.55
COWS Total Score During the Double-Blind Treatment Period Change from Baseline at Week 12/ET(n=126,140)	0.2 Units on a scale Standard Deviation 1.21	0.2 Units on a scale Standard Deviation 1.61
COWS Total Score During the Double-Blind Treatment Period Max. Double-Blind Period (DBP) Value (n=126,140)	1.3 Units on a scale Standard Deviation 1.60	1.4 Units on a scale Standard Deviation 1.84
COWS Total Score During the Double-Blind Treatment Period Change from Baseline to max. DBP Value (n=126,140)	0.9 Units on a scale Standard Deviation 1.53	0.9 Units on a scale Standard Deviation 1.90

SECONDARY outcome

Timeframe: Follow-Up (FU) Weeks 1 and 2

Population: Double-Blind Safety Population. Only participants with values at both Randomization Baseline and each respective visit were included in the change from Randomization Baseline analysis; n=number of participants analyzed for the given parameter at the specified timepoint.

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=108 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=94 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
COWS Total Score During the Post-Treatment Period FU Week 1 (n=68,83)	0.6 Units on a scale Standard Deviation 0.91	0.6 Units on a scale Standard Deviation 0.72
COWS Total Score During the Post-Treatment Period Change from Baseline at FU Week 1 (n=68,83)	0.2 Units on a scale Standard Deviation 0.99	0.1 Units on a scale Standard Deviation 0.90
COWS Total Score During the Post-Treatment Period FU Week 2 (n=78,91)	0.9 Units on a scale Standard Deviation 1.74	0.5 Units on a scale Standard Deviation 0.70
COWS Total Score During the Post-Treatment Period Change from Baseline at FU Week 2 (n=78,91)	0.7 Units on a scale Standard Deviation 1.83	-0.1 Units on a scale Standard Deviation 1.12
COWS Total Score During the Post-Treatment Period Max.FU Period Value (n=94,108)	1.1 Units on a scale Standard Deviation 1.67	0.7 Units on a scale Standard Deviation 0.76
COWS Total Score During the Post-Treatment Period Change to max. FU Period Value (n=94,108)	0.7 Units on a scale Standard Deviation 1.74	0.1 Units on a scale Standard Deviation 1.08

SECONDARY outcome

Timeframe: Screening, Weeks 1, 2, 3, 4, 5, 6 (or Early Termination)

Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Screening COWS less than(<)5 (n=387)	—	98.4 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Screening COWS=5-12 (n=387)	—	1.6 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Week 1 COWS <5 (n=353)	—	99.2 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Week 1 COWS=5-12 (n=353)	—	0.8 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Week 2 COWS <5 (n=327)	—	98.8 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Week 2 COWS 5-12 (n=327)	—	1.2 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Week 3 COWS <5 (n=316)	—	99.1 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Week 3 COWS 5-12 (n=316)	—	0.9 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Week 4 COWS <5 (n=210)	—	99.5 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Week 4 COWS 5-12 (n=210)	—	0.5 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Week 5 COWS <5 (n=138)	—	100 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Week 6 COWS <5 (n=375)	—	98.9 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Week 6 COWS 5-12 (n=375)	—	1.1 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Max. Titration Period Value COWS <5 (n=375)	—	96.8 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category Max. Titration Period Value COWS 5-12 (n=375)	—	3.2 Percentage of participants

SECONDARY outcome

Timeframe: Randomization Baseline, Weeks 1, 2, 4, 8, 12 (or Early Termination)

Population: Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Randomization Baseline COWS <5 (n=134,146)	100 Percentage of participants	100 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Week 1 COWS <5 (n=111,133)	98.5 Percentage of participants	99.1 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Week 1 COWS 5-12 (n=111,133)	1.5 Percentage of participants	0 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Week 1 COWS 13-24 (n=111,133)	0 Percentage of participants	0.9 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Week 2 COWS <5 (n=115,128)	98.4 Percentage of participants	99.1 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Week 2 COWS 5-12 (n=115,128)	1.6 Percentage of participants	0.9 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Week 4 COWS <5 (n=106,123)	100 Percentage of participants	99.1 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Week 4 COWS 5-12 (n=106,123)	0 Percentage of participants	0.9 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Week 8 COWS <5 (n=87,107)	98.1 Percentage of participants	100 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Week 8 COWS 5-12 (n=87,107)	1.9 Percentage of participants	0 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Week 12/ET COWS <5 (n=126,140)	97.9 Percentage of participants	98.4 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Week 12/ET COWS 5-12 (n=126,140)	2.1 Percentage of participants	0.8 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Week 12/ET COWS 13-24 (n=126,140)	0 Percentage of participants	0.8 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Max. DBP Value COWS <5 (n=126,140)	95.0 Percentage of participants	97.6 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Max. DBP Value COWS 5-12 (n=126,140)	5.0 Percentage of participants	1.6 Percentage of participants
Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category Max. DBP Value COWS 13-24 (n=126,140)	0 Percentage of participants	0.8 Percentage of participants

SECONDARY outcome

Timeframe: Follow-Up Weeks 1 and 2

Population: Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=108 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=94 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category FU Week 1 COWS <5 (n=68,83)	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category FU Week 2 COWS <5 (n=78,91)	95.6 Percentage of participants	100 Percentage of participants
Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category FU Week 2 COWS=5-12 (n=78,91)	4.4 Percentage of participants	0 Percentage of participants
Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category Maximum FU Period COWS <5 (n=94,108)	96.3 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category Maximum FU Period COWS=5-12 (n=94,108)	3.7 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Screening, Weeks 1, 2, 3, 4, 5, and 6

Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Screening (n=395)	—	4.1 Units on a scale Standard Deviation 4.92
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Week 1 (n=355)	—	3.5 Units on a scale Standard Deviation 4.31
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Change from Screening at Week 1 (n=346)	—	-0.7 Units on a scale Standard Deviation 4.71
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Week 2 (n=329)	—	3.0 Units on a scale Standard Deviation 3.66
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Change from Screening at Week 2 (n=320)	—	-1.2 Units on a scale Standard Deviation 4.64
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Week 3 (n=311)	—	2.7 Units on a scale Standard Deviation 4.17
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Change from Screening at Week 3 (n=304)	—	-1.4 Units on a scale Standard Deviation 5.24
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Week 4 (n=206)	—	2.2 Units on a scale Standard Deviation 2.92
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Change from Screening at Week 4 (n=199)	—	-2.1 Units on a scale Standard Deviation 4.92
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Week 5 (n=139)	—	2.2 Units on a scale Standard Deviation 2.96
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Change from Screening at Week 5 (n=133)	—	-2.4 Units on a scale Standard Deviation 4.42
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Week 6/ET (n=369)	—	3.0 Units on a scale Standard Deviation 4.41
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Change from Screening at Week 6/ET (n=359)	—	-1.2 Units on a scale Standard Deviation 5.36
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Max. SOWS (Titration Period) (n=369)	—	4.9 Units on a scale Standard Deviation 5.35
Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period Change from Screening at Max. SOWS (n=359)	—	0.7 Units on a scale Standard Deviation 5.51

SECONDARY outcome

Timeframe: Randomization Baseline, Weeks 1, 2, 4, 8, and 12

Population: Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
SOWS Total Score During the Double-Blind Treatment Period Randomization Baseline (n=134,146)	1.5 Units on a scale Standard Deviation 2.20	2.4 Units on a scale Standard Deviation 3.88
SOWS Total Score During the Double-Blind Treatment Period Week 1 (n=134,143)	2.3 Units on a scale Standard Deviation 3.69	3.0 Units on a scale Standard Deviation 4.27
SOWS Total Score During the Double-Blind Treatment Period Change from Baseline at Week 1 (n=134,143)	0.8 Units on a scale Standard Deviation 2.93	0.6 Units on a scale Standard Deviation 4.08
SOWS Total Score During the Double-Blind Treatment Period Week 2 (n=123,135)	1.9 Units on a scale Standard Deviation 3.11	3.5 Units on a scale Standard Deviation 6.56
SOWS Total Score During the Double-Blind Treatment Period Change from Baseline at Week 2 (n=123,135)	0.3 Units on a scale Standard Deviation 2.64	1.1 Units on a scale Standard Deviation 5.37
SOWS Total Score During the Double-Blind Treatment Period Max. SOWS, First 2 Weeks of Period (n=134,143)	4.4 Units on a scale Standard Deviation 5.11	6.3 Units on a scale Standard Deviation 7.72
SOWS Total Score During the Double-Blind Treatment Period Week 4 (n=105,122)	2.1 Units on a scale Standard Deviation 3.42	2.5 Units on a scale Standard Deviation 3.91
SOWS Total Score During the Double-Blind Treatment Period Change from Baseline at Week 4 (n=105,122)	0.5 Units on a scale Standard Deviation 2.39	0.1 Units on a scale Standard Deviation 3.57
SOWS Total Score During the Double-Blind Treatment Period Week 8 (n=85,110)	2.1 Units on a scale Standard Deviation 3.37	2.4 Units on a scale Standard Deviation 4.48
SOWS Total Score During the Double-Blind Treatment Period Change from Baseline at Week 8 (n=85,110)	0.6 Units on a scale Standard Deviation 2.92	0.1 Units on a scale Standard Deviation 3.83
SOWS Total Score During the Double-Blind Treatment Period Week 12 (n=134,143)	2.4 Units on a scale Standard Deviation 3.85	3.3 Units on a scale Standard Deviation 5.70
SOWS Total Score During the Double-Blind Treatment Period Change from Baseline at Week 12 (n=134,143)	0.9 Units on a scale Standard Deviation 3.01	0.9 Units on a scale Standard Deviation 5.11
SOWS Total Score During the Double-Blind Treatment Period Max. SOWS (Double-Blind Period) (n=134,143)	5.2 Units on a scale Standard Deviation 5.89	6.7 Units on a scale Standard Deviation 7.77
SOWS Total Score During the Double-Blind Treatment Period Change from Baseline at max. SOWs (n=134,143)	3.7 Units on a scale Standard Deviation 5.14	4.3 Units on a scale Standard Deviation 5.82

SECONDARY outcome

Timeframe: Follow-Up Weeks 1 and 2

Population: Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=110 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=96 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
SOWS Total Score During the Post-Treatment Period FU Week 1 (n=94,108)	2.3 Units on a scale Standard Deviation 3.69	2.6 Units on a scale Standard Deviation 4.91
SOWS Total Score During the Post-Treatment Period Change from Baseline at FU Week 1 (n=94,108)	0.8 Units on a scale Standard Deviation 3.21	0.2 Units on a scale Standard Deviation 4.12
SOWS Total Score During the Post-Treatment Period FU Week 2 (n=95,109)	2.5 Units on a scale Standard Deviation 3.67	2.7 Units on a scale Standard Deviation 5.26
SOWS Total Score During the Post-Treatment Period Change from Baseline at FU Week 2 (n=95,109)	1.0 Units on a scale Standard Deviation 3.35	0.2 Units on a scale Standard Deviation 4.49
SOWS Total Score During the Post-Treatment Period Max. SOWS (FU Period)(n=96,110)	4.5 Units on a scale Standard Deviation 5.45	4.7 Units on a scale Standard Deviation 6.73
SOWS Total Score During the Post-Treatment Period Change from Baseline at Max. SOWS, (n=96,110)	3.0 Units on a scale Standard Deviation 4.77	2.2 Units on a scale Standard Deviation 5.31

SECONDARY outcome

Timeframe: Screening, Week 6 (or Early Termination)

Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher scores indicating greater disability.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants Screening (n=405)	—	12.7 Units on a scale Standard Deviation 5.42
Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants End of Open-Label Titration Period (n=345)	—	9.0 Units on a scale Standard Deviation 5.62
Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants Change from Screening (n=343)	—	-3.9 Units on a scale Standard Deviation 4.91

SECONDARY outcome

Timeframe: Screening, Randomization Baseline

Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=280 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to Randomization Baseline in RMDQ Total Score Screening (n=277)	—	12.8 Units on a scale Standard Deviation 5.22
Change From Screening Period to Randomization Baseline in RMDQ Total Score Randomization Baseline (n=256)	—	7.9 Units on a scale Standard Deviation 5.14
Change From Screening Period to Randomization Baseline in RMDQ Total Score Change from Screening (n=255)	—	-4.8 Units on a scale Standard Deviation 4.95

SECONDARY outcome

Timeframe: Screening, Weeks 2, 4, 8, and 12

Population: ITT Population; imputation using the LOCF method for Week 12 only; Weeks 2, 4, 8 included observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score Week 12/ET (n=123,128)	-4.26 Units on a scale Standard Error 0.431	-4.33 Units on a scale Standard Error 0.440
Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score Week 2 (n=114,124)	-4.93 Units on a scale Standard Error 0.406	-3.88 Units on a scale Standard Error 0.423
Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score Week 4 (n=101,111)	-4.60 Units on a scale Standard Error 0.444	-3.90 Units on a scale Standard Error 0.467
Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score Week 8 (n=77,95)	-3.92 Units on a scale Standard Error 0.459	-4.50 Units on a scale Standard Error 0.514

SECONDARY outcome

Timeframe: Randomization Baseline, Weeks 2, 4, and 8

Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score Week 2 (n=111,118)	-0.19 Units on a scale Standard Error 0.321	0.54 Units on a scale Standard Error 0.334
Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score Week 4 (n=98,107)	0.32 Units on a scale Standard Error 0.397	1.02 Units on a scale Standard Error 0.420
Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score Week 8 (n=73,93)	0.41 Units on a scale Standard Error 0.408	-0.01 Units on a scale Standard Error 0.471

SECONDARY outcome

Timeframe: Screening, Randomization Baseline

Population: ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Screening.

Represents the score at Screening / score at Randomization Baseline in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=277 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Very Good	—	0.4 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Good	—	2.9 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Fair	—	9.4 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Poor	—	2.9 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Very Poor	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Very Good	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Good	—	5.8 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Fair	—	29.2 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Poor	—	8.7 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Very Poor	—	1.4 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Very Good	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Good	—	2.5 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Fair	—	22.0 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Poor	—	10.5 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Very Poor	—	1.4 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Very Good	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Good	—	0.4 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Fair	—	2.2 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Poor	—	0.4 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Very Poor	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Very Good	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Good	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Fair	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Poor	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Very Poor	—	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Screening, Randomization Baseline, or Early Termination

Population: Titration Period Safety Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Screening.

Represents the score at Screening / score at to end of the titration period in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=368 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Very Good	—	0.3 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Good	—	2.7 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Fair	—	7.6 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Poor	—	2.2 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Very Poor	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Very Good	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Good	—	5.4 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Fair	—	25.0 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Poor	—	7.6 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Very Poor	—	1.1 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Very Good	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Good	—	2.7 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Fair	—	27.2 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Poor	—	10.6 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Very Poor	—	1.4 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Very Good	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Good	—	0.3 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Fair	—	3.0 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Poor	—	2.2 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Very Poor	—	0.3 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Very Good	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Good	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Fair	—	0.0 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Poor	—	0.3 Percentage of participants
Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Very Poor	—	0.3 Percentage of participants

SECONDARY outcome

Timeframe: Randomization Baseline, Week 4

Population: ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Week 4 for each treatment.

Represents the score at Randomization Baseline / score at Week 4 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=126 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=109 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Very Good	8.7 Percentage of participants	7.3 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Good	0.8 Percentage of participants	3.7 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Fair	0.0 Percentage of participants	0.9 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Good / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Very Good	6.3 Percentage of participants	5.5 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Good	27.8 Percentage of participants	24.8 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Fair	13.5 Percentage of participants	7.3 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Good / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Very Good	1.6 Percentage of participants	0.9 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Good	15.1 Percentage of participants	15.6 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Fair	23.0 Percentage of participants	24.8 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Poor	2.4 Percentage of participants	1.8 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Fair / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Very Good	0.0 Percentage of participants	0.9 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Good	0.0 Percentage of participants	2.8 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Fair	0.0 Percentage of participants	2.8 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Poor	0.8 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Poor / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Very Good	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Good	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Fair	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Poor	0.0 Percentage of participants	0.9 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor Very Poor / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Randomization Baseline, Week 8

Population: ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Week 8 for each treatment.

Represents the score at Randomization Baseline / score at Week 8 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=112 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=88 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Very Good / Very Good	8.9 Percentage of participants	8.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Very Good / Good	3.6 Percentage of participants	5.7 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Very Good / Fair	1.8 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Very Good / Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Very Good / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Good / Very Good	8.0 Percentage of participants	5.7 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Good / Good	23.2 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Good / Fair	11.6 Percentage of participants	12.5 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Good / Poor	0.9 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Good / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Fair / Very Good	0.9 Percentage of participants	3.4 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Fair / Good	15.2 Percentage of participants	14.8 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Fair / Fair	21.4 Percentage of participants	17.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Fair / Poor	1.8 Percentage of participants	2.3 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Fair / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Poor / Very Good	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Poor / Good	0.0 Percentage of participants	1.1 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Poor / Fair	0.9 Percentage of participants	1.1 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Poor / Poor	0.9 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Poor / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Very Poor / Very Good	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Very Poor / Good	0.9 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Very Poor / Fair	0.0 Percentage of participants	2.3 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Very Poor / Poor	0.0 Percentage of participants	1.1 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor Very Poor / Very Poor	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: End of Open-Label Titration Period (Week 4, 5, or 6 or Early Termination)

Population: Titration Period Safety Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.

Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=369 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants Very Dissatisfied (n=369)	—	6.8 Percentage of participants
Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants Dissatisfied (n=369)	—	7.0 Percentage of participants
Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants Neither Satisfied or Dissatisfied (n=369)	—	11.7 Percentage of participants
Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants Satisfied (n=369)	—	40.7 Percentage of participants
Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants Very Satisfied (n=369)	—	33.9 Percentage of participants

SECONDARY outcome

Timeframe: Randomization Baseline

Population: ITT Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.

Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=278 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Satisfaction With Treatment at Randomization Baseline Very Dissatisfied (n=278)	—	5.4 Percentage of participants
Satisfaction With Treatment at Randomization Baseline Dissatisfied (n=278)	—	2.2 Percentage of participants
Satisfaction With Treatment at Randomization Baseline Neither Satisfied or Dissatisfied (n=278)	—	4.7 Percentage of participants
Satisfaction With Treatment at Randomization Baseline Satisfied (n=278)	—	46.0 Percentage of participants
Satisfaction With Treatment at Randomization Baseline Very Satisfied (n=278)	—	41.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 12 or Early Termination

Population: ITT Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.

Participants used an electronic tablet at the center to rate their overall treatment satisfaction with study drug during study participation using a 5-point categorical scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied).

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=128 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=125 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period Yes (n=125,128)	79.7 Percentage of participants	59.2 Percentage of participants
Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period No (n=125,128)	20.3 Percentage of participants	40.8 Percentage of participants

SECONDARY outcome

Timeframe: Screening, Week 6 (or Early Termination)

Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher scores indicates a better health state.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score Physical Functioning (n=366)	—	6.7 Score on a scale Standard Deviation 8.96
Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score Role-Physical (n=366)	—	7.7 Score on a scale Standard Deviation 9.48
Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score Bodily Pain (n=366)	—	9.8 Score on a scale Standard Deviation 8.44
Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score General Health (n=367)	—	2.3 Score on a scale Standard Deviation 6.54
Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score Vitality (n=366)	—	4.6 Score on a scale Standard Deviation 8.98
Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score Social Functioning (n=367)	—	5.0 Score on a scale Standard Deviation 11.01
Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score Role-Emotional (n=367)	—	3.4 Score on a scale Standard Deviation 12.19
Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score Mental Health (n=367)	—	2.3 Score on a scale Standard Deviation 8.76
Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score Physical Component Score (n=364)	—	8.2 Score on a scale Standard Deviation 7.90
Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score Mental Component Score (n=364)	—	1.6 Score on a scale Standard Deviation 10.05

SECONDARY outcome

Timeframe: Screening, Randomization Baseline

Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=280 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score Physical Functioning (n=276)	—	8.0 Score on a scale Standard Deviation 8.90
Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score Role-Physical (n=276)	—	9.1 Score on a scale Standard Deviation 9.40
Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score Bodily Pain (n=276)	—	11.6 Score on a scale Standard Deviation 7.91
Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score General Health (n=277)	—	3.1 Score on a scale Standard Deviation 6.65
Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score Vitality (n=276)	—	5.8 Score on a scale Standard Deviation 9.08
Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score Social Functioning (n=277)	—	7.0 Score on a scale Standard Deviation 10.27
Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score Role-Emotional (n=277)	—	4.7 Score on a scale Standard Deviation 12.04
Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score Mental Health (n=277)	—	3.5 Score on a scale Standard Deviation 8.29
Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score Physical Component Score (n=274)	—	9.6 Score on a scale Standard Deviation 7.77
Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score Mental Component Score (n=274)	—	2.9 Score on a scale Standard Deviation 9.69

SECONDARY outcome

Timeframe: Randomization Baseline, Week 12

Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Physical Functioning (n=122,125)	-1.44 Score on a scale Standard Error 0.666	-2.06 Score on a scale Standard Error 0.681
Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Role-Physical (n=124,126)	-2.59 Score on a scale Standard Error 0.701	-2.56 Score on a scale Standard Error 0.713
Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Bodily Pain (n=124,127)	-2.69 Score on a scale Standard Error 0.643	-5.07 Score on a scale Standard Error 0.655
Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey General Health Perceptions (n=124,126)	-2.10 Score on a scale Standard Error 0.536	-1.55 Score on a scale Standard Error 0.545
Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Vitality (n=123,127)	-2.77 Score on a scale Standard Error 0.762	-1.62 Score on a scale Standard Error 0.781
Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Social Functioning (n=124,127)	-1.69 Score on a scale Standard Error 0.734	-3.17 Score on a scale Standard Error 0.748
Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Role-Emotional (n=124,127)	-3.44 Score on a scale Standard Error 0.943	-2.57 Score on a scale Standard Error 0.963
Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Mental Health (n=124,127)	-2.93 Score on a scale Standard Error 0.697	-2.95 Score on a scale Standard Error 0.711
Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Physical Component Score (n=121,125)	-1.68 Score on a scale Standard Error 0.620	-2.70 Score on a scale Standard Error 0.635
Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Mental Component Score (n=121,125)	-2.98 Score on a scale Standard Error 0.749	-2.29 Score on a scale Standard Error 0.767

SECONDARY outcome

Timeframe: Screening, Week 12

Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Physical Functioning (n=123,126)	6.84 Score on a scale Standard Error 0.787	5.32 Score on a scale Standard Error 0.794
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Role-Physical (n=125,127)	6.78 Score on a scale Standard Error 0.802	5.68 Score on a scale Standard Error 0.805
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Bodily Pain (n=125,127)	8.78 Score on a scale Standard Error 0.743	6.39 Score on a scale Standard Error 0.747
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey General Health Perceptions (n=125,126)	1.07 Score on a scale Standard Error 0.609	1.28 Score on a scale Standard Error 0.611
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Vitality (n=125,127)	3.01 Score on a scale Standard Error 0.794	3.46 Score on a scale Standard Error 0.798
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Social Functioning (n=125,127)	5.57 Score on a scale Standard Error 0.768	3.58 Score on a scale Standard Error 0.771
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Role-Emotional (n=125,127)	1.22 Score on a scale Standard Error 0.975	0.99 Score on a scale Standard Error 0.979
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Mental Health (n=125,127)	0.47 Score on a scale Standard Error 0.748	0.09 Score on a scale Standard Error 0.752
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Physical Component Score (n=123,126)	8.09 Score on a scale Standard Error 0.715	6.42 Score on a scale Standard Error 0.721
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey Mental Component Score (n=123,126)	-0.45 Score on a scale Standard Error 0.808	-0.44 Score on a scale Standard Error 0.816

SECONDARY outcome

Timeframe: Screening, Week 6 (or Early Termination)

Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

The EQ 5D Health Questionnaire is a self completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index Screening (n=400)	—	0.68 Score on a scale Standard Deviation 0.174
Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index End of Open-Label (n=354)	—	0.80 Score on a scale Standard Deviation 0.134
Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index Change from Screening (n=346)	—	0.12 Score on a scale Standard Deviation 0.174

SECONDARY outcome

Timeframe: Screening, Week 6 (or Early Termination)

Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS Screening (n=406)	—	66.23 Score on a scale Standard Deviation 18.277
Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS End of Open-Label (n=367)	—	74.69 Score on a scale Standard Deviation 18.204
Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS Change from Screening (n=364)	—	8.16 Score on a scale Standard Deviation 19.398

SECONDARY outcome

Timeframe: Screening, Randomization Baseline

Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=280 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index Screening (n=272)	—	0.68 Score on a scale Standard Deviation 0.178
Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index Randomization Baseline (n=267)	—	0.82 Score on a scale Standard Deviation 0.120
Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index Change from Screening (n=260)	—	0.14 Score on a scale Standard Deviation 0.177

SECONDARY outcome

Timeframe: Screening, Randomization Baseline

Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=280 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS Screening (n=279)	—	67.02 Score on a scale Standard Deviation 18.518
Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS Randomization Baseline (n=276)	—	76.85 Score on a scale Standard Deviation 17.407
Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS Change from Screening (n=275)	—	9.84 Score on a scale Standard Deviation 19.692

SECONDARY outcome

Timeframe: Randomization Baseline, Week 12

Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=115 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=118 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index	-0.029 Score on a scale Standard Error 0.0120	-0.061 Score on a scale Standard Error 0.0118

SECONDARY outcome

Timeframe: Randomization Baseline, Week 12

Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=126 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=122 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS	-2.89 Score on a scale Standard Error 1.401	-3.61 Score on a scale Standard Error 1.432

SECONDARY outcome

Timeframe: Screening, Week 12

Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=117 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=121 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index	0.106 Score on a scale Standard Error 0.0124	0.085 Score on a scale Standard Error 0.0121

SECONDARY outcome

Timeframe: Screening, Week 12

Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=127 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=124 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS	7.01 Score on a scale Standard Error 1.454	4.75 Score on a scale Standard Error 1.465

SECONDARY outcome

Timeframe: Screening, Week 6 (or Early Termination)

Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment /absenteeism+presenteeism); and activity impairment. * work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). * impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). * overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). * activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain Percent Work Time Missed (n=119)	—	-1.3 Percentage Standard Deviation 16.66
Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain Percent Impairment While Working (n=112)	—	-22.4 Percentage Standard Deviation 26.95
Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain Percent Overall Work Impairment (n=110)	—	-21.6 Percentage Standard Deviation 29.83
Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain Percent Activity Impairment (n=363)	—	-27.2 Percentage Standard Deviation 24.45

SECONDARY outcome

Timeframe: Screening, Randomization Baseline

Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. * work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). * impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). * overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). * activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=280 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain Percent Work Time Missed (n=91)	—	-4.9 Percentage Standard Deviation 14.37
Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain Percent Impairment While Working (n=86)	—	-25.9 Percentage Standard Deviation 27.24
Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain Percent Overall Work Impairment (n=85)	—	-26.9 Percentage Standard Deviation 27.76
Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain Percent Activity Impairment (n=273)	—	-32.0 Percentage Standard Deviation 23.96

SECONDARY outcome

Timeframe: Randomization Baseline, Weeks 4, 8, and 12

Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=56 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=44 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain Week 4 (n=36,44)	-0.77 Percentage Standard Error 1.906	3.54 Percentage Standard Error 2.213
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain Week 8 (n=25,41)	1.41 Percentage Standard Error 2.592	4.29 Percentage Standard Error 3.507
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain Week 12/ET (n=40,50)	3.72 Percentage Standard Error 2.675	6.49 Percentage Standard Error 3.108

SECONDARY outcome

Timeframe: Randomization Baseline, Weeks 4, 8, and 12

Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=54 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=42 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain Week 4 (n=30,42)	-1.54 Percentage Standard Error 2.734	5.22 Percentage Standard Error 3.366
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain Week 8 (n=21,37)	-1.36 Percentage Standard Error 3.027	3.63 Percentage Standard Error 4.318
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain Week 12/ET (n=35,46)	4.39 Percentage Standard Error 2.918	6.77 Percentage Standard Error 3.475

SECONDARY outcome

Timeframe: Randomization Baseline, Weeks 4, 8, and 12

Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=53 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=42 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain Week 4 (n=30,42)	-2.03 Percentage Standard Error 3.147	5.31 Percentage Standard Error 3.894
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain Week 8 (n=21,37)	-0.66 Percentage Standard Error 3.666	8.69 Percentage Standard Error 5.276
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain Week 12/ET (n=35,46)	5.71 Percentage Standard Error 3.575	10.85 Percentage Standard Error 4.266

SECONDARY outcome

Timeframe: Randomization Baseline, Weeks 4, 8, and 12

Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=144 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=131 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain Week 4 (n=108,125)	1.98 Percentage Standard Error 1.626	6.23 Percentage Standard Error 1.768
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain Week 8 (n=85,112)	3.05 Percentage Standard Error 1.752	2.05 Percentage Standard Error 2.044
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain Week 12/ET (n=128,135)	6.41 Percentage Standard Error 1.758	10.56 Percentage Standard Error 1.818

SECONDARY outcome

Timeframe: Screening, Weeks 4, 8, and 12

Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=58 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=46 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain Week 4 (n=36,43)	-4.82 Percentage Standard Error 1.911	-0.09 Percentage Standard Error 2.147
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain Week 8 (n=24,40)	-3.01 Percentage Standard Error 2.123	-1.42 Percentage Standard Error 2.785
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain Week 12/ET (n=40,49)	-2.09 Percentage Standard Error 2.307	-1.00 Percentage Standard Error 2.612

SECONDARY outcome

Timeframe: Screening, Weeks 4, 8, and 12

Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=56 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=47 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain Week 12/ET (n=38,46)	-25.38 Percentage Standard Error 3.242	-16.18 Percentage Standard Error 3.642
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain Week 4 (n=33,42)	-31.03 Percentage Standard Error 3.151	-18.65 Percentage Standard Error 3.614
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain Week 8 (n=22,37)	-29.37 Percentage Standard Error 3.263	-16.43 Percentage Standard Error 4.374

SECONDARY outcome

Timeframe: Screening, Weeks 4, 8, and 12

Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=56 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=46 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain Week 4 (n=32,41)	-32.40 Percentage Standard Error 3.470	-19.84 Percentage Standard Error 3.992
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain Week 8 (n=21,37)	-29.37 Percentage Standard Error 3.608	-15.21 Percentage Standard Error 4.933
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain Week 12/ET (n=37,46)	-25.51 Percentage Standard Error 3.759	-15.16 Percentage Standard Error 4.268

SECONDARY outcome

Timeframe: Screening, Weeks 4, 8, and 12

Population: ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.

A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=145 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=133 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain Week 4 (n=109,125)	-31.24 Percentage Standard Error 1.829	-23.75 Percentage Standard Error 1.960
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain Week 8 (n=87,112)	-29.87 Percentage Standard Error 2.005	-25.25 Percentage Standard Error 2.279
Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain Week 12/ET (n=130,136)	-26.81 Percentage Standard Error 1.981	-18.62 Percentage Standard Error 2.025

SECONDARY outcome

Timeframe: Screening, Week 6 (or Early Termination)

Population: Titration Period Safety Population; the denominator for the percentage calculation is the number of participants who had both Screening value and End of Open-Label value.

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=362 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire Yes/Yes	—	0.3 Percentage of participants
Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire Yes/No	—	0.8 Percentage of participants
Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire No/Yes	—	2.5 Percentage of participants
Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire No/No	—	96.4 Percentage of participants

SECONDARY outcome

Timeframe: Screening, Randomization Baseline

Population: ITT Population; the denominator for the percentage calculation is the number of participants who had both Screening value and Randomization Baseline value.

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=272 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire Yes/Yes	—	0.4 Percentage of participants
Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire Yes/No	—	1.1 Percentage of participants
Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire No/Yes	—	2.9 Percentage of participants
Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire No/No	—	95.6 Percentage of participants

SECONDARY outcome

Timeframe: Screening, Randomization Baseline

Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=280 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain Screening (n=257)	—	11.4 Number of visits Standard Deviation 38.97
Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain Randomization Baseline (n=247)	—	5.6 Number of visits Standard Deviation 21.84
Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain Change from Screening (n=234)	—	-4.7 Number of visits Standard Deviation 39.19

SECONDARY outcome

Timeframe: Screening, Randomization Baseline

Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=280 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks Screening (n=264)	—	84.7 Dollars Standard Deviation 418.06
Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks Randomization Baseline (n=260)	—	51.8 Dollars Standard Deviation 360.94
Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks Change from Screening (n=248)	—	-41.8 Dollars Standard Deviation 522.53

SECONDARY outcome

Timeframe: Screening, Randomization Baseline

Population: ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Question 3b: nights stayed in the hospital, if answer to Q3a was yes.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=280 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital Screening (n=9)	—	0.1 Number of days Standard Deviation 0.33
Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital Randomization Baseline (n=3)	—	0.0 Number of days Standard Deviation 0.00
Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital Change from Screening (n=1)	—	0.0 Number of days Standard Deviation NA Standard Deviation not applicable as n=1

SECONDARY outcome

Timeframe: Screening, Week 6 (or Early Termination)

Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain Screening (n=373)	—	8.8 Number of visits Standard Deviation 33.07
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain Randomization Baseline (n=325)	—	5.4 Number of visits Standard Deviation 20.58
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain Change from Screening (n=308)	—	-3.0 Number of visits Standard Deviation 35.29

SECONDARY outcome

Timeframe: Screening, Week 6 (or Early Termination)

Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks Screening (n=388)	—	104.1 Dollars Standard Deviation 605.48
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks Randomization Baseline (n=343)	—	88.0 Dollars Standard Deviation 674.20
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks Change from Screening (n=329)	—	-28.3 Dollars Standard Deviation 548.03

SECONDARY outcome

Timeframe: Screening, Week 6 (or Early Termination)

Population: Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Question 3b: nights stayed in the hospital, if answer to Q3a was yes.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital Screening (n=9)	—	0.1 Number of days Standard Deviation 0.33
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital Randomization Baseline (n=3)	—	0.0 Number of days Standard Deviation 0.00
Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital Change from Screening (n=1)	—	0.0 Number of days Standard Deviation NA Standard Deviation not applicable as n=1

SECONDARY outcome

Timeframe: Randomization Baseline, Weeks 4, 8, and 12 (or Early Termination)

Population: ITT Population; the denominator for the percentage calculation is the number of participants who had both Randomization Baseline value and Post Randomization value for each treatment and visit. Imputation using the LOCF method.

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire Yes/Yes Week 4 (n=108, 123)	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire Yes/No Week 4 (n=108, 123)	0.8 Percentage of participants	3.7 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire No/Yes Week 4 (n=108, 123)	0.0 Percentage of participants	1.9 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire No/No Week 4 (n=108, 123)	99.2 Percentage of participants	94.4 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire Yes/Yes Week 8 (n=85, 110)	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire Yes/No Week 8 (n=85, 110)	0.9 Percentage of participants	1.2 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire No/Yes Week 8 (n=85, 110)	0.0 Percentage of participants	2.4 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire No/No Week 8 (n=85, 110)	99.1 Percentage of participants	96.5 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire Yes/Yes Week12/ET (n=129, 134)	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire Yes/No Week12/ET (n=129, 134)	0.0 Percentage of participants	3.1 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire No/Yes Week12/ET (n=129, 134)	0.7 Percentage of participants	1.6 Percentage of participants
Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire No/No Week 12/ET (n=129, 134)	99.3 Percentage of participants	95.3 Percentage of participants

SECONDARY outcome

Timeframe: Randomization Baseline, Weeks 4, 8, and 12

Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain Randomization Baseline (n=118,129)	6.6 Number of visits Standard Deviation 24.80	4.4 Number of visits Standard Deviation 18.10
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain Week 4 (n=100,110)	5.3 Number of visits Standard Deviation 37.99	6.5 Number of visits Standard Deviation 24.35
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain Change from Baseline at Week 4 (n=95,106)	-3.1 Number of visits Standard Deviation 46.85	0.1 Number of visits Standard Deviation 24.17
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain Week 8 (n=79,103)	3.3 Number of visits Standard Deviation 13.46	22.8 Number of visits Standard Deviation 179.55
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain Change from Baseline at Week 8 (n=74,100)	-2.6 Number of visits Standard Deviation 24.31	-1.2 Number of visits Standard Deviation 20.35
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain Week 12/ET (n=121,128)	4.2 Number of visits Standard Deviation 15.38	19.2 Number of visits Standard Deviation 153.80
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain Change from Baseline at Week 12/ET (n=112,119)	-4.1 Number of visits Standard Deviation 27.74	-0.3 Number of visits Standard Deviation 24.90

SECONDARY outcome

Timeframe: Randomization Baseline, Weeks 4, 8, and 12

Population: ITT Population, imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments Randomization Baseline (n=124,136)	11.3 Dollars Standard Deviation 33.77	96.4 Dollars Standard Deviation 518.89
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments Week 4 (n=104,119)	15.0 Dollars Standard Deviation 78.59	19.9 Dollars Standard Deviation 90.26
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments Change from Baseline at Week 4 (n=99,117)	4.4 Dollars Standard Deviation 79.92	-24.7 Dollars Standard Deviation 222.07
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments Week 8 (n=81,106)	16.7 Dollars Standard Deviation 54.33	146.2 Dollars Standard Deviation 1113.58
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments Change from Baseline at Week 8 (n=76,105)	7.5 Dollars Standard Deviation 42.52	-0.1 Dollars Standard Deviation 71.11
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments Week 12/ET (n=125,133)	29.3 Dollars Standard Deviation 177.85	113.0 Dollars Standard Deviation 913.41
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments Change from Baseline at Week 12/ET (n=119,128)	20.0 Dollars Standard Deviation 180.70	-47.8 Dollars Standard Deviation 461.95

SECONDARY outcome

Timeframe: Randomization Baseline, Weeks 4, 8, and 12

Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Question 3b: nights stayed in the hospital

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital Randomization Baseline (n=1,2)	0.0 Number of nights Standard Deviation 0.00	0.0 Number of nights Standard Deviation NA Standard deviation not applicable as n=1
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital Change from Baseline at Week 12/ET (n=0,0)	NA Number of nights Standard Deviation NA Mean and standard deviation not applicable as n=0	NA Number of nights Standard Deviation NA Mean and standard deviation not applicable as n=0
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital Week 4 (n=4,0)	NA Number of nights Standard Deviation NA Mean and standard deviation not applicable as n=0	0.3 Number of nights Standard Deviation 0.5
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital Change from Baseline at Week 4 (n=0,0)	NA Number of nights Standard Deviation NA Mean and standard deviation not applicable as n=0	NA Number of nights Standard Deviation NA Mean and standard deviation not applicable as n=0
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital Week 8 (n=1,1)	0.0 Number of nights Standard Deviation NA Standard deviation not applicable as n=1	99.0 Number of nights Standard Deviation NA Standard deviation not applicable as n=1
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital Change from Baseline at Week 8 (n=0,0)	NA Number of nights Standard Deviation NA Mean and standard deviation not applicable as n=0	NA Number of nights Standard Deviation NA Mean and standard deviation not applicable as n=0
Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital Week 12/ET (n=4,1)	0.0 Number of nights Standard Deviation NA standard deviation not applicable as n=1	24.8 Number of nights Standard Deviation 49.50

SECONDARY outcome

Timeframe: Screening, Weeks 4, 8, and 12

Population: ITT Population; the denominator for the percentage calculation is the number of participants who had both Screening value and Post Screening value for each treatment and visit. Imputation using the LOCF method.

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire Yes/Yes Week 4 (n=109,124)	0.0 Percentage of participants	0.9 Percentage of participants
Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire Yes/No Week 4 (n=109,124)	0.8 Percentage of participants	2.8 Percentage of participants
Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire No/Yes Week 4 (n=109,124)	1.6 Percentage of participants	2.8 Percentage of participants
Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire No/No Week 4 (n=109,124)	97.6 Percentage of participants	93.6 Percentage of participants
Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire Yes/Yes Week 8 (n=86,111)	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire Yes/No Week 8 (n=86, 111)	0.9 Percentage of participants	1.2 Percentage of participants
Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire No/Yes Week 8 (n=86, 111)	1.8 Percentage of participants	2.3 Percentage of participants
Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire No/No Week 8 (n=86, 111)	97.3 Percentage of participants	96.5 Percentage of participants
Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire Yes/Yes Week 12/ET (n=130,136)	0.0 Percentage of participants	0.8 Percentage of participants
Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire Yes/No Week 12/ET (n=130,136)	0.0 Percentage of participants	2.3 Percentage of participants
Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire No/Yes Week 12/ET (n=130,136)	2.2 Percentage of participants	3.8 Percentage of participants
Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire No/No Week 12/ET (n=130,136)	97.8 Percentage of participants	93.1 Percentage of participants

SECONDARY outcome

Timeframe: Screening, Weeks 4, 8, and 12

Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain Screening (n=121,136)	13.7 Number of visits Standard Deviation 43.07	8.8 Number of visits Standard Deviation 33.76
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain Week 4 (n=100,110)	5.3 Number of visits Standard Deviation 37.99	6.5 Number of visits Standard Deviation 24.35
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain Change from Screening at Week 4 (n=94,106)	-7.6 Number of visits Standard Deviation 58.56	0.8 Number of visits Standard Deviation 28.99
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain Week 8 (n=79,103)	3.3 Number of visits Standard Deviation 13.46	22.8 Number of visits Standard Deviation 179.55
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain Change from Screening at Week 8 (n=73,100)	-10.4 Number of visits Standard Deviation 44.61	16.7 Number of visits Standard Deviation 188.74
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain Week 12/ET (n=121,128)	4.2 Number of visits Standard Deviation 15.38	19.2 Number of visits Standard Deviation 153.80
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain Change from Screening at Week 12/ET (n=114,123)	-7.3 Number of visits Standard Deviation 41.80	13.2 Number of visits Standard Deviation 159.55

SECONDARY outcome

Timeframe: Screening, Weeks 4, 8, and 12

Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain Screening (n=126,138)	85.6 Dollars Standard Deviation 514.80	83.6 Dollars Standard Deviation 277.98
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain Week 4 (n=104,119)	15.0 Dollars Standard Deviation 78.59	19.9 Dollars Standard Deviation 90.26
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain Change from Screening at Week 4 (n=100,114)	-80.3 Dollars Standard Deviation 497.56	-79.8 Dollars Standard Deviation 315.79
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain Week 8 (n=81,106)	16.7 Dollars Standard Deviation 54.33	146.2 Dollars Standard Deviation 1113.58
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain Change from Screening at Week 8 (n=78,103)	-84.5 Dollars Standard Deviation 593.49	56.9 Dollars Standard Deviation 1174.87
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain Week 12/ET (n=125,133)	29.3 Dollars Standard Deviation 177.85	113.0 Dollars Standard Deviation 913.41
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain Change from Screening at Week 12/ET (n=120,128)	-58.1 Dollars Standard Deviation 563.65	32.1 Dollars Standard Deviation 944.71

SECONDARY outcome

Timeframe: Screening, Weeks 4, 8, and 12

Population: ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.

Question 3b: nights stayed in the hospital

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain Screening (n=6,3)	0.3 Number of nights Standard Deviation 0.58	0.0 Number of nights Standard Deviation 0.00
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain Week 4 (n=4,0)	NA Number of nights Standard Deviation NA Mean and Standard deviation not applicable as n=0	0.3 Number of nights Standard Deviation 0.50
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain Change from Screening at Week 4 (n=1,0)	NA Number of nights Standard Deviation NA Mean and Standard deviation not applicable as n=0	0.0 Number of nights Standard Deviation NA Standard deviation not applicable as n=1
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain Week 8 (n=1,1)	0.0 Number of nights Standard Deviation NA Standard deviation not applicable as n=1	99.0 Number of nights Standard Deviation NA Standard deviation not applicable as n=1
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain Change from Screening at Week 8 (n=0,0)	NA Number of nights Standard Deviation NA Mean and Standard deviation not applicable as n=0	NA Number of nights Standard Deviation NA Mean and Standard deviation not applicable as n=0
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain Week 12/ET (n=4,1)	0.0 Number of nights Standard Deviation NA Standard deviation not applicable as n=1	24.8 Number of nights Standard Deviation 49.50
Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain Change from Screening at Week 12/ET (n=1,0)	NA Number of nights Standard Deviation NA Mean and Standard deviation not applicable as n=0	0.0 Number of nights Standard Deviation NA Standard deviation not applicable as n=1

SECONDARY outcome

Timeframe: Open-Label Period

Population: Titration Period Safety Population

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Mean Oxycodone Average Daily Dose During the Open-Label Titration Period	—	45.8 mg Standard Deviation 22.61

SECONDARY outcome

Timeframe: Open-Label Period

Population: Titration Period Safety Population

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Mean Oxycodone Duration of Titration During the Open-Label Titration Period	—	31.0 days Standard Deviation 12.24

SECONDARY outcome

Timeframe: Open-Label Period

Population: Titration Period Safety Population

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Median Oxycodone Average Daily Dose During the Open-Label Titration Period	—	42.3 mg Inter-Quartile Range 22.61 • Interval 16.0 to 163.0

SECONDARY outcome

Timeframe: Open-Label Period

Population: Titration Period Safety Population

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Median Oxycodone Duration of Titration During the Open-Label Titration Period	—	35.0 days Inter-Quartile Range 12.24 • Interval 1.0 to 56.0

SECONDARY outcome

Timeframe: Double-Blind Period

Population: Double-Blind Safety Population

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period	63.6 mg Standard Deviation 34.02	70.1 mg Standard Deviation 33.67

SECONDARY outcome

Timeframe: Double-Blind Period

Population: Double-Blind Safety Population

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period	70.9 days Standard Deviation 27.80	62.7 days Standard Deviation 30.20

SECONDARY outcome

Timeframe: Double-Blind Period

Population: Double-Blind Safety Population

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period	59.6 mg Interval 19.0 to 160.0	60.0 mg Interval 20.0 to 152.0

SECONDARY outcome

Timeframe: Double-Blind Period

Population: Double-Blind Safety Population

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period	85.0 days Interval 1.0 to 102.0	84.0 days Interval 5.0 to 94.0

SECONDARY outcome

Timeframe: Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline

Population: Titration Period Safety Population; participants assessed at Week 6 had not been randomized to the Double-Blind Period; participants assessed at Randomization Baseline had been randomized to the Double-Blind Period.

Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone.

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period Oxycodone at Week 6/ET (n=77)	—	14.1 ng/mL Standard Deviation 22.27
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period Oxycodone at Randomization Baseline (n=267)	—	26.4 ng/mL Standard Deviation 28.84
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period Noroxycodone at Week 6/ET (n=77)	—	15.5 ng/mL Standard Deviation 26.50
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period Noroxycodone at Randomization Baseline (n=267)	—	29.9 ng/mL Standard Deviation 42.04

SECONDARY outcome

Timeframe: Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline

Population: Titration Period Safety Population; participants assessed at Week 6 had not been randomized to the Double-Blind Period; participants assessed at Randomization Baseline had been randomized to the Double-Blind Period.

Cobs of naltrexone and 6-β-naltrexol

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=410 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period Naltrexone at Week 6/ET (n=77)	—	4.6 pg/mL Standard Deviation 19.02
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period Naltrexone at Randomization Baseline (n=266)	—	14.6 pg/mL Standard Deviation 81.73
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period 6-β-naltrexol at Week 6/ET (n=77)	—	82.0 pg/mL Standard Deviation 305.91
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period 6-β-naltrexol at Randomization Baseline (n=266)	—	154.1 pg/mL Standard Deviation 595.80

SECONDARY outcome

Timeframe: Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12

Population: Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period Oxycodone at Baseline (n=127,140)	25.9 ng/mL Standard Deviation 28.73	27.0 ng/mL Standard Deviation 29.06
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period Oxycodone at Week 4 (n=0,116)	23.3 ng/mL Standard Deviation 26.90	NA ng/mL Standard Deviation NA Mean and standard deviation not applicable as n=0
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period Oxycodone at Week 8 (n=0,107)	23.1 ng/mL Standard Deviation 23.83	NA ng/mL Standard Deviation NA Mean and standard deviation not applicable as n=0
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period Oxycodone at Week 12/ET (n=1,137)	22.6 ng/mL Standard Deviation 26.98	0.0 ng/mL Standard Deviation NA Standard deviation not applicable as n=1
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period Noroxycodone at Baseline (n=127,140)	27.1 ng/mL Standard Deviation 34.67	33.1 ng/mL Standard Deviation 48.84
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period Noroxycodone at Week 4 (n=0,116)	25.5 ng/mL Standard Deviation 40.54	NA ng/mL Standard Deviation NA Mean and standard deviation not applicable as n=0
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period Noroxycodone at Week 8 (n=0,107)	26.2 ng/mL Standard Deviation 34.38	NA ng/mL Standard Deviation NA Mean and standard deviation not applicable as n=0
Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period Noroxycodone at Week 12/ET (n=1,137)	26.3 ng/mL Standard Deviation 40.67	0.0 ng/mL Standard Deviation NA Standard deviation not applicable as n=0

SECONDARY outcome

Timeframe: Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12

Population: Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.

Observed steady-state plasma concentration (Cobs) of naltrexone and 6-β-naltrexol

Outcome measures

Outcome measures
Measure	ALO-02 To ALO-02 n=146 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.	ALO-02 To Placebo n=134 Participants Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period 6-β-naltrexol at Week 12/ET (n=4,137)	55.6 pg/mL Standard Deviation 163.41	0.0 pg/mL Standard Deviation 0.0
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period Naltrexone at Baseline (n=127,139)	5.3 pg/mL Standard Deviation 16.48	24.9 pg/mL Standard Deviation 116.41
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period Naltrexone at Week 4 (n=3,115)	3.4 pg/mL Standard Deviation 14.65	0.0 pg/mL Standard Deviation 0.0
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period Naltrexone at Week 8 (n=3,107)	2.9 pg/mL Standard Deviation 11.13	0.0 pg/mL Standard Deviation 0.0
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period Naltrexone at Week 12/ET (n=4,137)	3.0 pg/mL Standard Deviation 12.67	0.0 pg/mL Standard Deviation 0.0
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period 6-β-naltrexol at Baseline (n=127,139)	97.5 pg/mL Standard Deviation 300.17	216.0 pg/mL Standard Deviation 800.32
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period 6-β-naltrexol at Week 4 (n=3,115)	86.1 pg/mL Standard Deviation 315.42	0.0 pg/mL Standard Deviation 0.0
Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period 6-β-naltrexol at Week 8 (n=3,107)	48.3 pg/mL Standard Deviation 156.42	0.0 pg/mL Standard Deviation 0.0

Adverse Events

Open ALO-02

Serious events: 3 serious events

Other events: 186 other events

Deaths: 0 deaths

ALO-02 To Placebo

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

ALO-02 To ALO-02

Serious events: 5 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Open ALO-02 n=410 participants at risk Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.	ALO-02 To Placebo n=134 participants at risk Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.	ALO-02 To ALO-02 n=146 participants at risk Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
Musculoskeletal and connective tissue disorders Back pain	1.2% 5/410 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	6.0% 8/134 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	2.1% 3/146 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	14.9% 61/410 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	2.2% 3/134 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	3.4% 5/146 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	2.2% 9/410 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	4.5% 6/134 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	5.5% 8/146 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	20.5% 84/410 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	3.7% 5/134 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	14.4% 21/146 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	9.0% 37/410 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	3.0% 4/134 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	6.2% 9/146 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	5.9% 24/410 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.75% 1/134 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	4.1% 6/146 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	7.3% 30/410 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	5.2% 7/134 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	1.4% 2/146 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	8.8% 36/410 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.75% 1/134 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.68% 1/146 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	6.3% 26/410 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	0.00% 0/134 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.	1.4% 2/146 • From the time of informed consent up to and including 28 calendar days after the last administration of the investigational product. The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60