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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514585-39-00 | EU Trial (CTIS) Number |
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The purpose of this study was to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in participants with Obsessive Compulsive Disorder (OCD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Troriluzole | Experimental | Participants received troriluzole 200 milligrams (mg) (100 mg*2) capsules orally once daily for the first two weeks and up-titrated to 280 mg (140 mg*2) capsules orally once daily for the next eight weeks, in the double-blind randomization phase. |
|
| Placebo | Placebo Comparator | Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Troriluzole | Drug | Capsules for oral administration. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Y-BOCS Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement) | Y-BOCS was a clinician-administered instrument used to assess the severity of obsessive compulsive disorder (OCD) symptoms and to monitor treatment response. The scale included 10 items: 5 items assessed obsessions and 5 items assessed compulsions. Each item was rated from 0 to 4, generating an obsessions subscale score (0-20), a compulsions subscale score (0-20), and a total score ranging from 0 to 40. Higher scores indicated greater OCD symptom severity. Negative change (or reduction in score) indicates improvement. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An Adverse event (AE) was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant, that did not necessarily have a causal relationship with treatment. An AE could be any unfavourable/unintended sign including an abnormal laboratory finding, symptom/disease temporally associated with the use of the study drug, whether or not considered related to it. A TEAE was defined as any AE that developed, worsened, or became serious after first dose of test treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Y-BOCS Total Score in the Baseline Y-BOCS = 22 or 23 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement) | Y-BOCS was a clinician-administered instrument used to assess the severity of obsessive compulsive disorder (OCD) symptoms and to monitor treatment response. The scale included 10 items: 5 items assessed obsessions and 5 items assessed compulsions. Each item was rated from 0 to 4, generating an obsessions subscale score (0-20), a compulsions subscale score (0-20), and a total score ranging from 0 to 40. Higher scores indicated greater OCD symptom severity. Negative change (or reduction in score) indicates improvement. |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alea Research | Phoenix | Arizona | 85012 | United States | ||
| ProScience Research Group |
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Participants who were stable on standard of care (SOC) medication and having an inadequate response along with Yale-Brown Obsessive Compulsive Scale (YBOCS) baseline score of (a) 22 or 23 or (b) 24 and above were randomized.
A total 589 participants were randomized, and 581 participants received at least one dose of study treatment. The study was conducted at multiple sites in the United States, United Kingdom, China and Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | Troriluzole | Participants received troriluzole 200 milligrams (mg) (100 mg*2) capsules orally once daily for the first two weeks and up-titrated to 280 mg (140 mg*2) capsules orally once daily for the next eight weeks, in the double-blind randomization phase. |
| FG001 | Placebo |
| 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 5, 2024 | Apr 24, 2026 |
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| Drug |
Drug- matching capsules for oral administration. |
|
| From first dose up to approximately 12 weeks |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 | The SDS was a participant-rated measure of functional disability. SDS was assessed in 3 domains: work/school (0-10), social life (0-10), and family life (0-10). The score from each domain was summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). Higher scores indicated a more severe impairment. | Baseline and Week 8 |
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 | The CGI-S was a clinician rated assessment of the participants current illness state on a 7-point scale. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicated a more severe illness. | Baseline and Week 8 |
| Baseline and Week 8 |
| Culver City |
| California |
| 90230 |
| United States |
| Kaizen Brain Center | La Jolla | California | 92037 | United States |
| Om Research LLC | Lancaster | California | 93534 | United States |
| CalNeuro Research Group | Los Angeles | California | 90024 | United States |
| Lumos Clinical Research Center, LLC | San Jose | California | 95124 | United States |
| Velocity Clinical Research | Santa Ana | California | 92704 | United States |
| California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California | 91403 | United States |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | United States |
| Mountain View Clinical Research | Denver | Colorado | 80209 | United States |
| Comprehensive Psychiatric Care | Norwich | Connecticut | 06360 | United States |
| Topaz Clinical Research | Apopka | Florida | 32703 | United States |
| CNS Research of Coral Springs | Coral Springs | Florida | 33067 | United States |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | United States |
| University of Florida Department of Psychiatry | Gainesville | Florida | 32606 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Med-Care Research | Miami | Florida | 33165 | United States |
| Ezy Medical Research, Co. | Miami | Florida | 33175 | United States |
| Advanced Research for Health Improvement | Naples | Florida | 34102 | United States |
| Harmony Clinical Research | North Miami Beach | Florida | 33162 | United States |
| dTMS Center LLC | Palm Beach | Florida | 33480 | United States |
| DMI Research | Pinellas Park | Florida | 33782 | United States |
| CenExel iResearch | Decatur | Georgia | 30030 | United States |
| Renew Health Clinical Research, LLC | Snellville | Georgia | 30078 | United States |
| University of Chicago Department of Psychiatry & Behavioral Neuroscience | Chicago | Illinois | 60637 | United States |
| AMR-Baber Research, Inc. | Naperville | Illinois | 60563 | United States |
| Collective Medical Research | Overland Park | Kansas | 66210 | United States |
| Continental Clinical Solutions, LLC | Towson | Maryland | 21204 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Psychiatric Care and Research Center | O'Fallon | Missouri | 63368 | United States |
| Boeson Research | Missoula | Montana | 59804 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08028 | United States |
| SPRI Clinical Trials, LLC | Brooklyn | New York | 11235 | United States |
| Manhattan Behavioral Medicine, PLLC | New York | New York | 10036 | United States |
| Richard H. Weisler, MD PA & Associates | Raleigh | North Carolina | 27609 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| American Clinical Research Institute (ACRI) | Dayton | Ohio | 45432 | United States |
| American Research Institute (ACRI) | Kettering | Ohio | 45439 | United States |
| North Star Medical Research, LLC | Middleburg Heights | Ohio | 44130 | United States |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Donald J. Garcia Jr., MD PA | Austin | Texas | 78737 | United States |
| Inquest Clinical Research | Baytown | Texas | 77521 | United States |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | United States |
| InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| Clinical Trial Network | Houston | Texas | 77074 | United States |
| AIM Trials | Plano | Texas | 75093 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Woodstock Research Center | Woodstock | Vermont | 05091 | United States |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| Chatham-Kent Clinical Trials Research Centre | Chatham | Ontario | N7L 1C1 | Canada |
| McMaster University, Hamilton Health Sciences | Hamilton | Ontario | L8S 1B7 | Canada |
| Queen's University | Kingston | Ontario | K7L 5G2 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| START Clinic for Mood and Anxiety Disorders | Toronto | Ontario | M4W 2N4 | Canada |
| University of Toronto / Centre for Addiction and Mental Health (CAMH) | Toronto | Ontario | M6J 1H4 | Canada |
| Beijing HuiLongGuan Hospital | Beijing | Changping District | 100085 | China |
| Peking University Sixth Hospital | Beijing | Haidian District | 100083 | China |
| Hangzhou Seventh People's Hospital | Hangzhou | Hangzhou City | 310063 | China |
| Tianjin Anding Hospital | Tianjin | Hexi District | 300222 | China |
| The Second Xiangya Hospital of Central South University | Xiangya | Hunan | 410008 | China |
| Nanjing Brain Hospital | Nanjing | Jiangsu | 210029 | China |
| Shanghai Mental Health Center | Shanghai | Minhang District | 201108 | China |
| Wuhan Mental Health Center | Wuhan | Qiaokou District | 430022 | China |
| The First Affiliated Hospital of Jinan University | Guangzhou | Tianhe District | 510660 | China |
| Mental Health Center, West China Hospital, Sichuan University | Chengdu | Wuhou District | 610041 | China |
| First Hospital of Hebei Medical University | Shijiazhuang | Yuhua District | 050001 | China |
| ASST FBF SACCO - Ospedale Universitario Luigi Sacco | Milan | 20157 | Italy |
| University School of Medicine of Napoli Federico II | Naples | 80131 | Italy |
| University of Pisa | Pisa | 56126 | Italy |
| University of Turin - university hospital san luigi gonzaga | Turin | 10043 | Italy |
| Amsterdam UMC, locatie AMC | Amsterdam | 1100 | Netherlands |
| Leiden University Medical Center (LUMC) | Leiden | 2333 | Netherlands |
| Hospital Universitario de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Centro de Salud Mental La Corredoria | Oviedo | 33011 | Spain |
| Centro de Salud San Juan | Salamanca | 37005 | Spain |
| Hospital Álvaro Cunqueiro | Vigo | 36312 | Spain |
| MAC Clinical Research | Stockton-on-Tees | County Durham | TS17 6EW | United Kingdom |
| Stemax Consult - Healthcare Services Ltd | Stony Stratford | Northamptonshire | MK19 6FG | United Kingdom |
| MAC Clinical Research - South Staffordshire | Cannock | South Staffordshire | WS11 0BN | United Kingdom |
| MAC Clinical Research-Lancashire | Blackpool | FY2 0JH | United Kingdom |
| MAC Clinical Research | Leeds | LS10 1DU | United Kingdom |
| MAC Clinical Research -- Merseyside | Liverpool | L34 1BH | United Kingdom |
| Greater Manchester Mental Health NHS Foundation Trust | Manchester | M25 3BL | United Kingdom |
| Bioluminux Ltd | Milton Keynes | MK15 0DU | United Kingdom |
| Kingshill Research Centre | Swindon | SN3 6BW | United Kingdom |
| MAC Clinical Research-- South Yorkshire | Tankersley | S75 3DL | United Kingdom |
Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase. |
|
| Treated |
|
| Y-BOCS Score >=24 Cohort | Participants who were randomized in the YBOCS total score ≥ 24 cohort |
|
| Y-BOCS Score 22-23 Cohort | Participants who were randomized in the Y-BOCS Score 22 - 23 cohort |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population included enrolled participants who received at least one dose of blinded study therapy (troriluzole or placebo).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Troriluzole | Participants received troriluzole 200 mg capsules orally once daily for the first two weeks and up-titrated to 280 mg capsules orally once daily for the next eight weeks, in the double-blind randomization phase. |
| BG001 | Placebo | Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase. |
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Baseline (YBOCS) total score | Y-BOCS was a clinician-administered instrument used to assess the severity of OCD symptoms and to monitor treatment response. The scale included 10 items: 5 items assessed obsessions and 5 items assessed compulsions. Each item was rated from 0 to 4, generating an obsessions subscale score (0-20), a compulsions subscale score (0-20), and a total score ranging from 0 to 40. Higher scores indicated greater OCD symptom severity. This included both the Y-BOCS Score ≥ 24 cohort and the Y-BOCS Score 22 - 23 cohort. | Mean | Standard Deviation | units on a scale |
|
| 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 | Change From Baseline in the Y-BOCS Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement) | Y-BOCS was a clinician-administered instrument used to assess the severity of obsessive compulsive disorder (OCD) symptoms and to monitor treatment response. The scale included 10 items: 5 items assessed obsessions and 5 items assessed compulsions. Each item was rated from 0 to 4, generating an obsessions subscale score (0-20), a compulsions subscale score (0-20), and a total score ranging from 0 to 40. Higher scores indicated greater OCD symptom severity. Negative change (or reduction in score) indicates improvement. | Modified Intent to Treat (mITT) population included randomized participants who received at least 1 dose of study therapy and had a non-missing baseline assessment and at least one non-missing post-baseline on-treatment efficacy assessment (based on YBOCS in person only) during the randomization phase. Participants with available data were analyzed. As planned, the primary analysis was conducted on the baseline Y-BOCS ≥24 stratification cohort. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 8 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An Adverse event (AE) was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant, that did not necessarily have a causal relationship with treatment. An AE could be any unfavourable/unintended sign including an abnormal laboratory finding, symptom/disease temporally associated with the use of the study drug, whether or not considered related to it. A TEAE was defined as any AE that developed, worsened, or became serious after first dose of test treatment | Safety Population included enrolled participants who received at least one dose of blinded study therapy (troriluzole or placebo). | Posted | Count of Participants | Participants | From first dose up to approximately 12 weeks |
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| Secondary | Change From Baseline in Sheehan Disability Scale (SDS) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 | The SDS was a participant-rated measure of functional disability. SDS was assessed in 3 domains: work/school (0-10), social life (0-10), and family life (0-10). The score from each domain was summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). Higher scores indicated a more severe impairment. | mITT population. Participants with available data were analyzed. As planned, the primary analysis was conducted on the baseline Y-BOCS ≥24 stratification cohort. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impression of Severity (CGI-S) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 | The CGI-S was a clinician rated assessment of the participants current illness state on a 7-point scale. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicated a more severe illness. | mITT population. Participants with available data were analyzed. As planned, the primary analysis was conducted on the baseline Y-BOCS ≥24 stratification cohort. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in the Y-BOCS Total Score in the Baseline Y-BOCS = 22 or 23 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement) | Y-BOCS was a clinician-administered instrument used to assess the severity of obsessive compulsive disorder (OCD) symptoms and to monitor treatment response. The scale included 10 items: 5 items assessed obsessions and 5 items assessed compulsions. Each item was rated from 0 to 4, generating an obsessions subscale score (0-20), a compulsions subscale score (0-20), and a total score ranging from 0 to 40. Higher scores indicated greater OCD symptom severity. Negative change (or reduction in score) indicates improvement. | mITT population included randomized participants who received at least 1 dose of study therapy and had non-missing baseline assessment and at least one non-missing post-baseline on-treatment efficacy assessment (based on YBOCS in person only) during randomization phase. Participants with available data were analyzed. Additional pre-specified analysis on baseline Y-BOCS = 22 or 23 stratification cohort also conducted. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 8 |
|
For Adverse Events: From first dose up to approximately 12 weeks For All-cause Mortality: From Day 1 up to approximately 12 weeks
For AEs: Safety Population included enrolled participants who received at least one dose of blinded study therapy (troriluzole or placebo).
For All-Cause Mortality: Randomized population included enrolled subjects who received a treatment assignment from the Interactive Response Technology (IRT) system.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Troriluzole | Participants received troriluzole 200 mg capsules orally once daily for the first two weeks and up-titrated to 280 mg capsules orally once daily for the next eight weeks, in the double-blind randomization phase. | 0 | 294 | 3 | 292 | 116 | 292 |
| EG001 | Placebo | Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase. | 0 | 295 | 2 | 289 | 85 | 289 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Obsessive-compulsive disorder | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Biohaven Pharmaceuticals, Inc. | +12034040410 | clinicaltrials@biohavenpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2023 | Apr 24, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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| Black or African American |
|
| White |
|
| Other |
|
| Not Reported |
|
Confidence interval was based on repeated confidence interval method described by Jennison and Turnbull. |
| Superiority |
| Units |
|---|
| Counts |
|---|
| Participants |
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| Participants |
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Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase.
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