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The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of risankizumab 150 mg/mL formulation in PFS in adult participants with moderate to severe plaque psoriasis. The study included a 30-day screening period, a 28-week treatment period with study visits at Weeks 0, 4, 16 and 28, and a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug. Study drug dosing consisted of 3 self-administered, subcutaneous (SC) doses on Weeks 0, 4, and 16. Dosing on Week 4 was self-administered at home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab | Experimental | Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16 |
|
| Placebo | Placebo Comparator | Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Risankizumab 150 mg (150 mg/mL) in prefilled syringes, self-administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100. | At Week 16 |
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. | At Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Negative values indicate an improvement from baseline. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Derm Ctr /ID# 210366 | Birmingham | Alabama | 35205 | United States | ||
| Alliance Dermatology and MOHs /ID# 210645 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33947295 | Derived | Blauvelt A, Gordon KB, Lee P, Bagel J, Sofen H, Lockshin B, Soliman AM, Geng Z, Zhan T, Alperovich G, Stein Gold L. Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis. J Dermatolog Treat. 2022 Jun;33(4):2085-2093. doi: 10.1080/09546634.2021.1914812. Epub 2021 May 5. |
| Label | URL |
|---|---|
| Related Info. | View source |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Intent-to-treat (ITT) population: all randomized participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Risankizumab | Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16 |
| FG001 | Placebo | Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2020 | Feb 19, 2021 |
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| Placebo solution for risankizumab | Drug | Placebo solution in prefilled syringes, self-administered subcutaneously |
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| At Week 16 |
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear at Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. | At Week 16 |
| Baseline, Week 4, and Week 16 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Hull Dermatology, PA /ID# 210305 | Rogers | Arkansas | 72758 | United States |
| Anaheim Clinical Trials LLC /ID# 212559 | Anaheim | California | 92801-2658 | United States |
| Wallace Medical Group, Inc. /ID# 210403 | Beverly Hills | California | 90211 | United States |
| Dermatology Res. Assoc., CA /ID# 210402 | Los Angeles | California | 90045 | United States |
| Integrative Skin Science and Research /ID# 212551 | Sacramento | California | 95815-4500 | United States |
| Mosaic Dermatology /ID# 210780 | Santa Monica | California | 90404 | United States |
| Skin Care Research, LLC /ID# 210514 | Boca Raton | Florida | 33486-2269 | United States |
| ACCEL Research Sites /ID# 212709 | DeLand | Florida | 32720 | United States |
| Multi-Speciality Research Associates /ID# 211625 | Lake City | Florida | 32055-8835 | United States |
| GSI Clinical Research, LLC /ID# 210330 | Margate | Florida | 33063 | United States |
| Suncoast Clinical Research /ID# 210874 | New Port Richey | Florida | 34652 | United States |
| Ormond Medical Arts Pharmaceutical Research Center /ID# 212781 | Ormond Beach | Florida | 32174-6302 | United States |
| Progressive Medical Research /ID# 210877 | Port Orange | Florida | 32127 | United States |
| Precision Clinical Research /ID# 212921 | Sunrise | Florida | 33351-7311 | United States |
| Lenus Research & Medical Group /ID# 212584 | Sweetwater | Florida | 33172 | United States |
| Treasure Valley Dermatology /ID# 212707 | Boise | Idaho | 83713-0997 | United States |
| Sneeze, Wheeze, & Itch Associates, LLC /ID# 212562 | Normal | Illinois | 61761 | United States |
| The Indiana Clinical Trials Center /ID# 210205 | Plainfield | Indiana | 46168 | United States |
| Forefront Dermatology /ID# 210520 | Louisville | Kentucky | 40202-2862 | United States |
| DS Research /ID# 210272 | Louisville | Kentucky | 40241-6162 | United States |
| David Fivenson, MD, PLC /ID# 210193 | Ann Arbor | Michigan | 48103 | United States |
| Clarkston Skin Research /ID# 210197 | Clarkston | Michigan | 48346 | United States |
| Henry Ford Medical Center /ID# 211598 | Detroit | Michigan | 48202-3046 | United States |
| Cleaver Dermatology /ID# 210300 | Kirksville | Missouri | 63501-5362 | United States |
| Advanced Dermatology of the Midlands /ID# 212763 | Omaha | Nebraska | 68144-1105 | United States |
| Skin Specialists, PC /ID# 211490 | Omaha | Nebraska | 68144 | United States |
| Psoriasis Treatment Ctr NJ /ID# 210837 | East Windsor | New Jersey | 08520 | United States |
| Skin Laser and Surgery Specialists of NY and NJ /ID# 210208 | Hackensack | New Jersey | 07601-1997 | United States |
| DermResearchCenter of NY, Inc. /ID# 210652 | Stony Brook | New York | 11790 | United States |
| WDC Cosmetic and Research, PLLC /ID# 210372 | Wilmington | North Carolina | 28403 | United States |
| Lynn Health Science Institute (LHSI) /ID# 213216 | Oklahoma City | Oklahoma | 73112 | United States |
| Clinical Partners, LLC /ID# 210642 | Johnston | Rhode Island | 02919 | United States |
| Palmetto Clinical Trial Services /ID# 210368 | Fountain Inn | South Carolina | 29644-1928 | United States |
| Coastal Carolina Research Ctr /ID# 213069 | Mt. Pleasant | South Carolina | 29464 | United States |
| Arlington Research Center, Inc /ID# 210344 | Arlington | Texas | 76011 | United States |
| Center for Clinical Studies - Houston (Binz) /ID# 210361 | Houston | Texas | 77004-8097 | United States |
| Progressive Clinical Research /ID# 210359 | San Antonio | Texas | 78229 | United States |
| Acclaim Dermatology /ID# 212252 | Sugar Land | Texas | 77479-2645 | United States |
| Dr. Samuel Sanchez, PSC /ID# 211142 | Caguas | 00727 | Puerto Rico |
| Pan American Center for Oncology Trials, LLC /ID# 212445 | Rio Piedras | 00935 | Puerto Rico |
| Clinical Research Puerto Rico /ID# 211144 | San Juan | 0090 | Puerto Rico |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population: all randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Risankizumab | Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16 |
| BG001 | Placebo | Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Prior Use of Systemic Biologic for Psoriasis | Count of Participants | Participants | No |
| |||||||||||||||
| Static Physician Global Assessment (sPGA) Score at Baseline | The sPGA is an investigator assessment of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. | Count of Participants | Participants | No |
| ||||||||||||||
| Psoriasis Area and Severity Index (PASI) Score at Baseline | The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Body Surface Area (BSA) Psoriasis Involvement at Baseline | Mean | Standard Deviation | Percentage of body surface area affected |
| |||||||||||||||
| Duration of Plaque Psoriasis | Mean | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100. | Intent-to-treat (ITT) population: all randomized participants; those with missing data were imputed as non-responders | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 16 |
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| Primary | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. | Intent-to-treat (ITT) population: all randomized participants; those with missing data were imputed as non-responders | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 16 |
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| Secondary | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100. | Intent-to-treat (ITT) population: all randomized participants; those with missing data were imputed as non-responders | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 16 |
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| Secondary | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear at Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. | Intent-to-treat (ITT) population: all randomized participants; those with missing data were imputed as non-responders | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 16 |
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| Other Pre-specified | Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16 | The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Negative values indicate an improvement from baseline. | Intent-to-treat (ITT) population: all randomized participants with a non-missing baseline measurement and at least one post-baseline value | Posted | Least Squares Mean | 95% Confidence Interval | percent change from Baseline | Baseline, Week 4, and Week 16 |
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Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed, up to 48 weeks. In addition, serious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study is administered until 20 weeks have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
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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 | Risankizumab | Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16 | 0 | 105 | 1 | 105 | 0 | 105 |
| EG001 | Placebo | Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16 | 0 | 52 | 0 | 52 | 0 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2020 | Feb 19, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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| Male |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or other Pacific Islander |
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| Multiple |
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| ≥1 |
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| Score of 4 |
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