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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019871-31 | EudraCT Number |
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This is a 2-part (6 weeks duration for each part), randomized, double-blind, placebo-controlled study in participants with rheumatoid arthritis. The hypothesis is that etoricoxib (60 mg and 90 mg) administration will demonstrate superior efficacy compared to placebo after 6 weeks of treatment, as measured by the greater mean improvement from baseline in the Disease Activity Score C-Reactive Protein (DAS-28 CRP), and by the greater mean improvement in Patient Global Assessment of Pain (PGAP) from baseline over 6 weeks of treatment. Additionally, the added benefit of increasing the dose of etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etoricoxib 60 mg/Etoricoxib 60 mg | Experimental | The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily for 6 weeks in Part 1 and Part 2 of the study. |
|
| Etoricoxib 60 mg/Etoricoxib 90 mg | Experimental | The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily for 6 weeks in Part 1 and etoricoxib 90 mg tablets administered orally once daily for 6 weeks in Part 2 of the study. |
|
| Etoricoxib 90 mg | Experimental | The etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg tablets administered orally once daily for 6 weeks in Part 1 and will not participate in Part 2 of the study. |
|
| Placebo | Placebo Comparator | The placebo treatment sequence will receive matching placebo to etoricoxib tablets administered orally once daily for 6 weeks in Part 1 and will not participate in Part 2 of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoricoxib 60 mg | Drug | One tablet orally once daily for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib vs. Placebo) | Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed. | Baseline and Week 6 |
| Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib vs. Placebo) | A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed. | Baseline and Week 6 |
| Percentage of Participants Who Experienced at Least One Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. | Up to 112 days |
| Percentage of Participants Who Discontinued Study Drug Due to an AE | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg) | Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27502582 | Result | Bickham K, Kivitz AJ, Mehta A, Frontera N, Shah S, Stryszak P, Popmihajlov Z, Peloso PM. Evaluation of two doses of etoricoxib, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), in the treatment of Rheumatoid Arthritis in a double-blind, randomized controlled trial. BMC Musculoskelet Disord. 2016 Aug 8;17:331. doi: 10.1186/s12891-016-1170-0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etoricoxib 60 mg | The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study. |
| FG001 | Etoricoxib 90 mg | The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study. |
| FG002 | Etoricoxib 60 mg/Etoricoxib 60 mg | The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study. |
| FG003 | Etoricoxib 60/Etoricoxib 90mg | The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study. |
| FG004 | Placebo | The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 |
|
| ||||||||||||||||||
| Part 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etoricoxib 60 mg | The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study. |
| BG001 | Etoricoxib 90 mg | The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib vs. Placebo) | Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed. | The modified intention-to-treat (mITT) population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and Week 6 |
Up to 112 days
The All Participants as Treated (APaT) population was used for the analysis of safety data in this study and consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
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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 | Etoricoxib 60 mg - Part 1 | The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000077613 | Etoricoxib |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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| Etoricoxib 90 mg | Drug | One tablet orally once daily for 6 weeks. |
|
|
| Placebo to Etoricoxib 60 mg | Drug | One tablet orally once daily for 6 weeks. |
|
| Placebo to Etoricoxib 90 mg | Drug | One tablet orally once daily for 6 weeks |
|
| Up to Week 12 |
| Baseline and Week 6 |
| Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg) | A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed. | Baseline and Week 6 |
| Average Change From Week 6 in Patient Global Assessment of Pain Over Weeks 10 and 12 in Part 2 Among Pain Inadequate Responders From Part 1 | A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). In those participants who were considered inadequate responders to etoricoxib 60 mg in Part 1 (defined as a participant with <50% improvement from baseline in PGAP [VAS] at Week 6), the incremental benefit of increasing the etoricoxib dose from 60 mg (in Part 1) to 90 mg (in Part 2) compared to remaining on 60 mg in Part 2 was evaluated via average change from Week 6 over Weeks 10 and 12 in Patient Global Assessment of Pain score. Therefore, data for only these 2 arms are displayed. | Week 6 and Week 10 to Week 12 |
| Technical problem |
|
| Protocol Violation |
|
| Physician Decision |
|
| Non-compliance with study drug |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Placebo | The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Disease Activity Score using C reactive protein (DAS28-CRP) | The DAS28-CRP index (0 - 10 Range) is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. (N = 732, 426, 103 for Etoricoxib 60 mg, Etoricoxib 90 mg, and Placebo). | Mean | Standard Deviation | Scores on a scale |
|
| Patient Global Assessment of Pain | A participant overall assessment of pain on a visual analog scale (VAS) were assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). (N = 751, 430, 108 for Etoricoxib 60 mg, Etoricoxib 90 mg, and Placebo) | Mean | Standard Deviation | Scores on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Etoricoxib 60 mg | The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study. |
| OG001 | Etoricoxib 90 mg | The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study. |
| OG002 | Placebo | The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study. |
|
|
|
| Primary | Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib vs. Placebo) | A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed. | The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and Week 6 |
|
|
|
|
| Secondary | Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg) | Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed. | The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and Week 6 |
|
|
|
|
| Secondary | Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg) | A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed. | The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and Week 6 |
|
|
|
|
| Secondary | Average Change From Week 6 in Patient Global Assessment of Pain Over Weeks 10 and 12 in Part 2 Among Pain Inadequate Responders From Part 1 | A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). In those participants who were considered inadequate responders to etoricoxib 60 mg in Part 1 (defined as a participant with <50% improvement from baseline in PGAP [VAS] at Week 6), the incremental benefit of increasing the etoricoxib dose from 60 mg (in Part 1) to 90 mg (in Part 2) compared to remaining on 60 mg in Part 2 was evaluated via average change from Week 6 over Weeks 10 and 12 in Patient Global Assessment of Pain score. Therefore, data for only these 2 arms are displayed. | This population (a subpopulation of the mITT population) was composed of pain inadequate responder (PIRs) in Part 1. PIRs were defined as participants with <50% improvement from baseline in Patient Global Assessment of Pain (VAS) at Week 6 and received at least one dose of study medication in Part 2. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Week 6 and Week 10 to Week 12 |
|
|
|
|
| Primary | Percentage of Participants Who Experienced at Least One Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. | All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population. | Posted | Number | Percentage of participants | Up to 112 days |
|
|
|
| Primary | Percentage of Participants Who Discontinued Study Drug Due to an AE | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. | ASaT population defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population. | Posted | Number | Percentage of participants | Up to Week 12 |
|
|
|
| 7 |
| 819 |
| 25 |
| 819 |
| EG001 | Etoricoxib 90 mg - Part 1 | The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study. | 2 | 467 | 17 | 467 |
| EG002 | Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2 | The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study. | 4 | 350 | 6 | 350 |
| EG003 | Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2 | The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study. | 5 | 363 | 6 | 363 |
| EG004 | Placebo - Part 1 | The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study. | 0 | 118 | 6 | 118 |
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroduodenitis | Gastrointestinal disorders | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Chest discomfort | General disorders | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
|
| Pyomyositis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Difference in least squares mean |
| -10.70 |
| 2-Sided |
| 95 |
| -14.74 |
| -6.66 |
| Superiority or Other (legacy) |