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| Name | Class |
|---|---|
| Worldwide Clinical Trials | OTHER |
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The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.
This was a multicenter, open-label, uncontrolled, single-arm, 24-week, extension study to assess safety, efficacy, and treatment retention during maintenance treatment.
Eligible patients had completed 1 of 2 primary efficacy and safety studies of the higher-bioavailability BNX sublingual tablet formulation (primary study OX219-006 [NCT01908842] or OX219-007 [NCT01848054]). The total duration of study treatment was 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label BNX sublingual tablets | Experimental | Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Higher bioavailability BNX sublingual tablets | Drug | Once daily, open-label treatment with higher bioavailability BNX sublingual tablets for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Reporting Treatment-Emergent Adverse Events | Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets | Day 1 through week 24 |
| Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events | Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets | Day 1 through week 24 |
| Number of Patients Reporting Treatment-Emergent Serious Adverse Events | Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets | Day 1 throught week 24 |
| Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events | Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets | Day 1 through week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Retention in Treatment in the Safety Population | Retention in treatment by visit in the safety population at weeks 4, 8, 12, 16, 20, and 24, defined as the number of patients receiving treatment on the day of the visit (± 5 days for each visit) | Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kent Hoffman | TRY Research, 406 Lake Howell Road, Maitland, Florida 32751 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson County | Alabama | United States | ||||
A total of 668 patients who completed primary study OX219-006 (NCT01908842) or OX219-007 (NCT01848054) were enrolled. Three patients entered the study without taking any study medication and were excluded. A total of 665 patients were included in the data analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Safety Population | Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score |
Mean change from primary study baseline in COWS total scores during the 24-week open-label, extension study; COWS scores range from 0 to 48, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for COWS |
| Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint |
| Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score | Mean change from primary study baseline in SOWS total scores during the 24-week open-label, extension study; SOWS scores range from 0 to 64, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for SOWS | Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint |
| Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores | Mean change from primary study baseline in VAS craving scores during the 24-week open-label, extension study; VAS craving scores range from 0 ("no cravings") to 100 mm ("most intense craving I have ever had"); study endpoint was defined as the last post-baseline value recorded for VAS craving | Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint |
| Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP) | Question 1 of the WPAI:SHP asks patients to provide a "yes" or "no" response to the question "Are you employed?"; The percentage of patients employed at the end of the 24-week open-label, extension study was calculated by subtracting the percentage of previously employed patients not employed at study end from the percentage of previously unemployed patients who were employed by study end | Study Endpoint |
| Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP | Mean change from primary study baseline to week 24 of the open-label, extension study for questions 2-4 of the WPAI:SHP; Question 2: During the past 7 days, how many hours did you miss from work because of problems associated with your opioid dependence?; Question 3: During the past 7 days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; Question 4: During the past 7 days, how many hours did you actually work? | Week 24 |
| Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP | Mean change from primary study baseline to week 24 of the open-label extension study for questions 5-6 of the WPAI:SHP; Question 5: During the past 7 days, how much did your opioid dependence affect your productivity while you were working?; Question 6: During the past 7 days, how much did your opioid dependence affect your ability to do regular daily activities, other than work at a job?; Questions 5 and 6 of the WPAI:SHP are scored on an 11-point scale (0 = problem had no effect; 10 = problem completely prevented me from doing my work/daily activities) | Week 24 |
| Marion County |
| Alabama |
| United States |
| Winston County | Alabama | United States |
| Maricopa County | Arizona | United States |
| Los Angeles County | California | United States |
| San Diego County | California | United States |
| Broward County | Florida | United States |
| Columbia County | Florida | United States |
| Duval County | Florida | United States |
| Jacksonville Metropolitan Area | Florida | United States |
| Miami-Dade County | Florida | United States |
| Orlando Metropolitan Area | Florida | United States |
| Osceola County | Florida | United States |
| Palm Beach County | Florida | United States |
| DeKalb County | Georgia | United States |
| Chicago Metropolitan Area | Illinois | United States |
| Baltimore County | Maryland | United States |
| Bristol County | Massachusetts | United States |
| Rankin County | Mississippi | United States |
| Saint Louis Metropolitan Area | Missouri | United States |
| Warren County | New Jersey | United States |
| Oklahoma County | Oklahoma | United States |
| Portland Metropolitan Area | Oregon | United States |
| Delaware County | Pennsylvania | United States |
| Philadelphia County | Pennsylvania | United States |
| Charleston County | South Carolina | United States |
| Salt Lake County | Utah | United States |
| Benton County | Washington | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | OX219-006 Completers | Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects. |
| BG001 | OX219-007 Completers | Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Duration of Opioid Use | Median | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Retention in Treatment in the Safety Population | Retention in treatment by visit in the safety population at weeks 4, 8, 12, 16, 20, and 24, defined as the number of patients receiving treatment on the day of the visit (± 5 days for each visit) | Safety population | Posted | Number | 95% Confidence Interval | participants | Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24 |
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| Secondary | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score | Mean change from primary study baseline in COWS total scores during the 24-week open-label, extension study; COWS scores range from 0 to 48, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for COWS | Safety population; patient population at day 1 (n=658) is lower than overall safety population (n=665) due to missing data | Posted | Mean | 95% Confidence Interval | units on a scale | Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint |
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| Secondary | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score | Mean change from primary study baseline in SOWS total scores during the 24-week open-label, extension study; SOWS scores range from 0 to 64, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for SOWS | Safety population; patient population at day 1 (n=650) is lower than overall safety population (n=665) due to missing data | Posted | Mean | 95% Confidence Interval | units on a scale | Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint |
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| Secondary | Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores | Mean change from primary study baseline in VAS craving scores during the 24-week open-label, extension study; VAS craving scores range from 0 ("no cravings") to 100 mm ("most intense craving I have ever had"); study endpoint was defined as the last post-baseline value recorded for VAS craving | Safety population; patient population at day 1 (n=646) is lower than overall safety population (n=665) due to missing data | Posted | Mean | 95% Confidence Interval | units on a scale | Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint |
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| Secondary | Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP) | Question 1 of the WPAI:SHP asks patients to provide a "yes" or "no" response to the question "Are you employed?"; The percentage of patients employed at the end of the 24-week open-label, extension study was calculated by subtracting the percentage of previously employed patients not employed at study end from the percentage of previously unemployed patients who were employed by study end | Safety population; patients with missing data were excluded from the analysis and are reflected in the number of patients analyzed | Posted | Number | percentage of patients | Study Endpoint |
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| Secondary | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP | Mean change from primary study baseline to week 24 of the open-label, extension study for questions 2-4 of the WPAI:SHP; Question 2: During the past 7 days, how many hours did you miss from work because of problems associated with your opioid dependence?; Question 3: During the past 7 days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; Question 4: During the past 7 days, how many hours did you actually work? | Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed | Posted | Mean | 95% Confidence Interval | hours | Week 24 |
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| Secondary | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP | Mean change from primary study baseline to week 24 of the open-label extension study for questions 5-6 of the WPAI:SHP; Question 5: During the past 7 days, how much did your opioid dependence affect your productivity while you were working?; Question 6: During the past 7 days, how much did your opioid dependence affect your ability to do regular daily activities, other than work at a job?; Questions 5 and 6 of the WPAI:SHP are scored on an 11-point scale (0 = problem had no effect; 10 = problem completely prevented me from doing my work/daily activities) | Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed | Posted | Mean | 95% Confidence Interval | units on a scale | Week 24 |
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| Primary | Number of Patients Reporting Treatment-Emergent Adverse Events | Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets | Safety population | Posted | Number | participants | Day 1 through week 24 |
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| Primary | Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events | Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets | Safety population | Posted | Number | participants | Day 1 through week 24 |
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| Primary | Number of Patients Reporting Treatment-Emergent Serious Adverse Events | Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets | Safety population | Posted | Number | participants | Day 1 throught week 24 |
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| Primary | Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events | Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets | Safety population | Posted | Number | participants | Day 1 through week 24 |
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Day 1 through Week 24 of Open-Label Extension Study
Safety population (N=665)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Population | Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses of buprenorphine/naloxone between 5.7/1.4 mg and 17.1/4.2 mg mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects. | 15 | 665 | 41 | 665 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heroin toxicity | Injury, poisoning and procedural complications | MedDRA 16.0. | Systematic Assessment | Condition led to death; non-treatment-emergent; not related to study drug. |
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| Hypertensive and atherosclerotic cardiovascular disease | Cardiac disorders | MedDRA 16.0. | Systematic Assessment | Condition led to death; non-treatment-emergent, not related to study drug. |
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| Non-small cell lung cancer | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0. | Systematic Assessment | Moderate, treatment-emergent; not related to study drug. |
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| Respiratory syncytial virus bronchitis | Infections and infestations | MedDRA 16.0. | Systematic Assessment | Moderate, treatment-emergent; not related to study drug. |
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| Depression | Psychiatric disorders | MedDRA 16.0. | Systematic Assessment | Mild, treatment-emergent; not related to study drug in one patient; severe, treatment-emergent; possibly related to study drug in another patient. |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0. | Systematic Assessment | Moderate, treatment-emergent; not related to study drug. |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0. | Systematic Assessment | Moderate, treatment-emergent; not related to study drug. |
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| Anal abscess | Infections and infestations | MedDRA 16.0. | Systematic Assessment | Severe, treatment-emergent; unlikely related to study drug. |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.0. | Systematic Assessment | Moderate, treatment-emergent; not related to study drug. |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 16.0. | Systematic Assessment | Severe, treatment-emergent; not related to study drug. |
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| Metabolic encephalopathy | Nervous system disorders | MedDRA 16.0. | Systematic Assessment | Severe, treatment-emergent; not related to study drug. |
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| Urinary tract infection | Infections and infestations | MedDRA 16.0. | Systematic Assessment | Severe, treatment-emergent; not related to study drug. |
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| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 16.0. | Systematic Assessment | Severe, treatment-emergent; not related to study drug. |
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| Intentional overdose | Social circumstances | MedDRA 16.0. | Systematic Assessment | Severe, non-treatment-emergent; not related to study drug. |
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| Worsening of opioid dependence | Psychiatric disorders | MedDRA 16.0. | Systematic Assessment | Moderate, non-treatment-emergent; not related to study drug in two patients. |
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| Bipolar depression | Psychiatric disorders | MedDRA 16.0. | Systematic Assessment | Severe, non-treatment-emergent; unlikely related to study drug. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 16.0. | Systematic Assessment | Treatment-emergent. |
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| Headache | Nervous system disorders | MedDRA 16.0. | Systematic Assessment | Treatment-emergent. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kent Hoffman, DO | TRY Research | (407) 691-3960 | Suboxdoc1@yahoo.com |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Week 16 |
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| Week 20 |
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| Week 24 |
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