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This study will evaluate the efficacy and safety of vibegron, a beta-3 adrenergic receptor (β3-AR) agonist, in the treatment of pain associated with irritable bowel syndrome (IBS) due to IBS with predominant diarrhea (IBS-D) or mixed episodes of diarrhea and constipation (IBS-M).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibegron 75 mg | Experimental | Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks. |
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| Placebo | Placebo Comparator | Participants will receive matching placebo orally once daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibegron | Drug | oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12 | An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 30% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks). | Baseline; Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants | Global improvement assessment asks participants to evaluate their current IBS status by asking the following question: How would you rate your IBS signs or symptoms overall over the past 7 days?: (1) significantly relieved; (2) moderately relieved; (3) slightly relieved; (4) unchanged; (5) slightly worse; (6) moderately worse; (7) significantly worse. A responder was defined as a participant who answered that their symptoms were either moderately relieved or significantly relieved. A participant with a missing GIS response was considered to be a non-responder. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synexus Clinical Research US, Inc.-Simon Williamson Clinic | Birmingham | Alabama | 35211 | United States | ||
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Of 806 participants screened for this study, 222 were randomized (after a 2-week, single-blind placebo Run-in Period), and 222 received 1 dose of double-blind study drug in the Treatment Period (Safety Set: placebo, N = 111; vibegron, N = 111).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]). |
| 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 | Nov 19, 2019 | Jul 8, 2021 |
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| Placebo | Drug | oral administration |
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| Week 12 |
| Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks | An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 40% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks). | Baseline; 12 weeks |
| Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks | An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 50% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks). | Baseline; 12 weeks |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | TEAEs are defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment. | from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Day 113 or Early Withdrawal plus 28 days) |
| Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12 | The investigator determined whether a change was clinically meaningful. | Baseline; Week 12 |
| Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12 | Clinical relevance was determined by the investigator. | Baseline; Week 12 |
| Clinical Research Associates |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Alabama Medical Group, PC | Mobile | Alabama | 36693 | United States |
| Hope Research Institute | Chandler | Arizona | 85224 | United States |
| Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC | Chandler | Arizona | 85224 | United States |
| Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC | Mesa | Arizona | 85206 | United States |
| Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC | Mesa | Arizona | 85213 | United States |
| Synexus - Clinical Research Advantage, Inc. - Central Phoenix Medical Clinic LLC | Phoenix | Arizona | 85020 | United States |
| GW Research Inc - ClinEdge-PPDS | Chula Vista | California | 91910 | United States |
| Triwest Research Associates, LLC | La Mesa | California | 91942 | United States |
| VA Long Beach Healthcare System - NAVREF | Long Beach | California | 90822 | United States |
| Southern California Research Institute Medical Group, Inc. | Los Angeles | California | 90045 | United States |
| Desta Digestive Disease Medical Center | San Diego | California | 92114 | United States |
| Medical Associates Research Group, Inc. | San Diego | California | 92123 | United States |
| Torrance Clinical Research | Torrance | California | 90505 | United States |
| Medical Research Center of Connecticut LLC | Hamden | Connecticut | 06518 | United States |
| Mayo Clinic - Division of Gastroenterology | Jacksonville | Florida | 32224 | United States |
| Florida Center For Gastroenterology | Largo | Florida | 33777 | United States |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | United States |
| Palm Beach Research - ClinEdge - PPDS | West Palm Beach | Florida | 33409 | United States |
| RNA America, LLC | Sugar Hill | Georgia | 30518 | United States |
| Investigators Research Group, LLC | Indianapolis | Indiana | 46268 | United States |
| Mandeville Private Physician Group, LLC | Mandeville | Louisiana | 70471 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Clinical Research Institute of Michigan | Chesterfield | Michigan | 48047 | United States |
| Synexus Clinical Research US, Inc. - Rita B. Chuang, MD, LLC | Henderson | Nevada | 89502 | United States |
| Advanced Research Institute | Reno | Nevada | 89511 | United States |
| Atrium Healthcare Center for Digestive Health | Charlotte | North Carolina | 28204 | United States |
| Carolina Digestive Diseases | Greenville | North Carolina | 27834 | United States |
| East Carolina Gastroenterology | Jacksonville | North Carolina | 28546 | United States |
| Dayton Gastroenterology, Inc. | Beavercreek | Ohio | 45440 | United States |
| Central Sooner Research | Norman | Oklahoma | 73071 | United States |
| Synexus Clinical Research US, Inc. - Anderson | Anderson | South Carolina | 29621 | United States |
| Chattanooga Medical Research Inc | Chattanooga | Tennessee | 37404 | United States |
| Clinical Research Solutions PC | Jackson | Tennessee | 38305 | United States |
| DHAT Research Institute | Garland | Texas | 75044 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Synexus Clinical Research US, Inc.-Plano | Plano | Texas | 75093 | United States |
| Synexus Clinical Research US, Inc. - Wasatch Peak Family Practice | Layton | Utah | 84041 | United States |
| Advanced Research Institute | South Ogden | Utah | 84405 | United States |
| FG001 | Vibegron 75 mg | Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M). |
| COMPLETED |
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| NOT COMPLETED |
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Baseline data are reported for all randomized participants who took at least one dose of double-blind study medication and had at least one evaluable post-randomization weekly abdominal pain intensity (API) score (i.e., where evaluable was considered a minimum of 5 diary entries in a week).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]). |
| BG001 | Vibegron 75 mg | Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M). |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Abdominal Pain Intensity Score (Stratified Strata) | Stratified strata was based on the randomization stratifications. Participants were asked to rate their IBS-related abdominal pain at its worst in the past 24 hours on a 0- to 10-point numeric rating scale, where 0 = no pain and 10 = the worst possible pain. | Count of Participants | Participants |
| |||||||||||||||
| IBS Subtype (Stratified Strata) | Stratified strata was based on the randomization stratifications. The Rome IV criteria classifies IBS into 4 distinct subtypes based on predominant stool consistency: IBS with predominantly constipation (IBS-C), IBS with predominantly diarrhea (IBS-D), IBS with mixed episodes of diarrhea and constipation (IBS-M), and IBS with unknown subtype (IBS-U). IBS-D: ≥ 25% diarrhea and < 25% constipation. IBS-M: ≥ 25% constipation and ≥ 25% diarrhea. | Count of Participants | Participants |
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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 | Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12 | An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 30% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks). | Full Analysis Set for IBS-D participants: all randomized participants with IBS-D who who took at least one dose of double-blind study medication and had at least one evaluable post-randomization weekly API score (i.e., where evaluable was considered a minimum of 5 diary entries in a week) | Posted | Count of Participants | Participants | Baseline; Week 12 |
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| Secondary | Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants | Global improvement assessment asks participants to evaluate their current IBS status by asking the following question: How would you rate your IBS signs or symptoms overall over the past 7 days?: (1) significantly relieved; (2) moderately relieved; (3) slightly relieved; (4) unchanged; (5) slightly worse; (6) moderately worse; (7) significantly worse. A responder was defined as a participant who answered that their symptoms were either moderately relieved or significantly relieved. A participant with a missing GIS response was considered to be a non-responder. | Full Analysis Set: all randomized participants who took at least one dose of double-blind study medication and had at least one evaluable post-randomization weekly API score (i.e., where evaluable was considered a minimum of 5 diary entries in a week) | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks | An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 40% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks). | Full Analysis Set for IBS-D participants | Posted | Count of Participants | Participants | Baseline; 12 weeks |
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| Secondary | Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks | An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 50% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks). | Full Analysis Set for IBS-D participants | Posted | Count of Participants | Participants | Baseline; 12 weeks |
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| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | TEAEs are defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment. | Safety Analysis Set: all participants who received at least 1 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. | Posted | Count of Participants | Participants | from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Day 113 or Early Withdrawal plus 28 days) |
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| Secondary | Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12 | The investigator determined whether a change was clinically meaningful. | Safety Analysis Set | Posted | Count of Participants | Participants | Baseline; Week 12 |
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| Secondary | Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12 | Clinical relevance was determined by the investigator. | Safety Analysis Set | Posted | Count of Participants | Participants | Baseline; Week 12 |
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from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Week 14)
Treatment-emergent adverse events (TEAEs), defined as events that began or worsened in severity after the first dose of the double-blind study treatment through 14 days after the last dose of study treatment, are reported for members of the Safety Analysis Set, comprised of all participants who received at least 1 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 | Placebo | Participants received matching placebo, orally, once daily for 12 weeks. Participants were stratified by Baseline abdominal pain intensity (API) score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and irritable bowel syndrome (IBS) subtype (IBS with predominant diarrhea [IBS-D] versus IBS with mixed episodes of diarrhea and constipation [IBS-M]). | 0 | 111 | 1 | 111 | 19 | 111 |
| EG001 | Vibegron 75 mg | Participants received vibegron 75 milligrams (mg), orally, once daily for 12 weeks. Participants were stratified by Baseline API score (< 6 versus ≥ 6 on a 0- to 10-point numeric rating scale) and IBS subtype (IBS-D versus IBS-M). | 0 | 111 | 2 | 111 | 13 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDra 23.1 | Systematic Assessment |
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| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDra 23.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDra 23.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDra 23.1 | Systematic Assessment |
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| Irritable bowel syndrome | Gastrointestinal disorders | MedDra 23.1 | Systematic Assessment |
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| Bacteriuria | Infections and infestations | MedDra 23.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDra 23.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDra 23.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDra 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDra 23.1 | Systematic Assessment |
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| Leukocyturia | Renal and urinary disorders | MedDra 23.1 | Systematic Assessment |
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The Sponsor does not object to publication by Institution or Principal Investigator (PI) of results of the Trial based on information collected or generated by the Institution or PI. However, the Institution and PI are required to provide the Sponsor with an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed to ensure against any inadvertent disclosure of Sponsor Confidential Information or unprotected Sponsor Inventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Information, Clinical Trial Results | Urovant Sciences | 949-226-6029 | info@urovant.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2020 | Jul 8, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003248 | Constipation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C000608232 | N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide |
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| Male |
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| Black or African American |
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| Captured as Other |
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| American Indian or Alaska Native |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| ≥ 6 |
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| IBS-M |
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