Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

September 10, 2020 updated by: AbbVie

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5006
        • Womens and Childrens Hospital /ID# 127538
  • Austria
      • Salzburg, Austria, 5020
        • LKH Salzburg and Paracelsus /ID# 123457
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medizinische Universitat Wien /ID# 120802
  • Belgium
      • Brussels, Belgium, 1020
        • Hosp Univ Enfants Reine Fabiol /ID# 120795
    • Bruxelles-Capitale
      • Jette, Bruxelles-Capitale, Belgium, 1090
        • UZ Brussel /ID# 120798
      • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
        • Cliniques Universitaires Saint Luc /ID# 120797
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre /ID# 127777
  • Czechia
      • Olomouc, Czechia, 779 00
        • Palacky University /ID# 131388
      • Plzen, Czechia, 305 99
        • Univ Hosp, Plzen, CZ /ID# 120813
  • Hungary
      • Gyor, Hungary, 9023
        • Petz Aladar Megyei Oktato Korh /ID# 124323
      • Szekszard, Hungary, 7100
        • Balassa Janos County Hospital /ID# 128474
  • Israel
      • Be'er Sheva, Israel, 84101
        • Soroka Medical Ctr /ID# 147338
      • Be'er Ya'akov, Israel, 70300
        • Assaf Harofeh Medical Center /ID# 147791
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus /ID# 120827
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center /ID# 120830
      • Petah Tikva, Israel, 4920235
        • Schneider Childrens Med Ctr /ID# 120821
      • Ramat Gan, Israel, 5262100
        • Sheba Medical Center /ID# 124324
      • Rehovot, Israel, 76100
        • Kaplan Medical Center /ID# 150245
  • Japan
      • Osaka, Japan, 558-8558
        • Osaka General Medical Center /ID# 124535
    • Fukuoka
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital /ID# 125476
    • Gunma
      • Maebashi-shi, Gunma, Japan, 371-8511
        • Gunma University Hospital /ID# 126345
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124482
    • Hyogo
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • The Hospital of Hyogo College of Medicine /ID# 131665
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City Univ Medical Ctr /ID# 147763
      • Yokohama-shi, Kanagawa, Japan, 230-0012
        • Saiseikai Yokohamashi Tobu /ID# 124486
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 989-3126
        • Miyagi Children's Hospital /ID# 125475
    • Saitama
      • Saitama-shi, Saitama, Japan, 330-8777
        • Saitama Children's Medical Center /ID# 124485
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital /ID# 124536
      • Setagaya-ku, Tokyo, Japan, 157-8535
        • National Center for Child Health and Development /ID# 125203
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Canterbury District Health Boa /ID# 120837
  • Poland
      • Rzeszow, Poland, 35-210
        • Gabinet Lekarski Bartosz Korcz /ID# 120916
      • Wroclaw, Poland, 50-369
        • Samodzielny Publiczny Szpital /ID# 120839
    • Lodzkie
      • Lodz, Lodzkie, Poland, 93-338
        • Polish Mothers Memorial Hosp /ID# 148497
    • Malopolskie
      • Cracow, Malopolskie, Poland, 30-663
        • Uni Szpital Dzieciecy w Krakowie /ID# 120915
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 00-635
        • Centrum Zdrowia MDM /ID# 120910
  • Slovakia
      • Banska Bystrica, Slovakia, 974 09
        • FN s poliklinikou F.D. Rooseve /ID# 120847
      • Bratislava, Slovakia, 821 01
        • Univerzitna Nemocnica Bratislava /ID# 120842
    • Zilinsky Kraj
      • Martin, Zilinsky Kraj, Slovakia, 036 01
        • Univerzitna nemocnica Martin /ID# 120844
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Univ Vall d'Hebron /ID# 120856
      • Madrid, Spain, 28009
        • Hospital Infantil Universitario Nino Jesus /ID# 121862
  • United Kingdom
      • Glasgow, United Kingdom, G3 8SJ
        • Royal Hosp for Sick Children /ID# 120864
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary, Ma /ID# 120862
    • London, City Of
      • London, London, City Of, United Kingdom, E1 1BB
        • The Royal London Hospital /ID# 120861
      • London, London, City Of, United Kingdom, NW3 2QG
        • The Royal Free Hospital /ID# 123142
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Childrens Hospital LA /ID# 147452
      • San Francisco, California, United States, 94143-2204
        • Univ California, San Francisco /ID# 120901
    • Florida
      • Orlando, Florida, United States, 32806
        • Arnold Palmer Hosp Children /ID# 120898
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital /ID# 121858
      • Atlanta, Georgia, United States, 30342
        • Children's Ctr Digestive, US /ID# 121855
    • Illinois
      • Chicago, Illinois, United States, 60637-1443
        • University of Chicago /ID# 120904
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Ctr /ID# 120900
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University /ID# 120908
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital /ID# 124551
      • Boston, Massachusetts, United States, 02115
        • Boston Childrens Hospital /ID# 147714
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic - Rochester /ID# 121056
      • Saint Paul, Minnesota, United States, 55114
        • Minnesota Gastroenterology P.A /ID# 120895
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Goryeb Chidlren's Hospital /ID# 121860
    • New York
      • New Hyde Park, New York, United States, 11040
        • North Shore University Hospital /ID# 120905
      • Rochester, New York, United States, 14642
        • Univ Rochester Med Ctr /ID# 127776
    • Washington
      • Tacoma, Washington, United States, 98405
        • Multicare Institute for Research and Innovation /ID# 147716

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of UC for at least 12 weeks prior to screening, confirmed by endoscopy with biopsy.
  • Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of 2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both.

Exclusion Criteria:

  • Subject with Crohn's disease (CD) or indeterminate colitis (IC).
  • Current diagnosis of fulminant colitis and/or toxic megacolon.
  • Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
  • Chronic recurring infections or active tuberculosis (TB).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adalimumab Induction Standard Dose
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
Biological: Adalimumab
Subcutaneous (SC) injection
Other Names:
  • Humira
Biological: Placebo
Subcutaneous (SC) injection
Experimental: Adalimumab Induction High Dose
Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
Biological: Adalimumab
Subcutaneous (SC) injection
Other Names:
  • Humira
Experimental: Adalimumab Induction High Dose - Open Label
(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
Biological: Adalimumab
Subcutaneous (SC) injection
Other Names:
  • Humira
Placebo Comparator: Maintenance Placebo
(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.
Biological: Adalimumab
Subcutaneous (SC) injection
Other Names:
  • Humira
Biological: Placebo
Subcutaneous (SC) injection
Experimental: Adalimumab Maintenance Standard Dose
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg [maximum dose of 40 mg] every other week). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after second flare.
Biological: Adalimumab
Subcutaneous (SC) injection
Other Names:
  • Humira
Experimental: Adalimumab Maintenance High Dose
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg [maximum dose of 40 mg] every week). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after second flare.
Biological: Adalimumab
Subcutaneous (SC) injection
Other Names:
  • Humira

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period
Time Frame: Week 8
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 sub scores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in PMS indicates improvement. Clinical remission was defined as a PMS ≤ 2 and no individual subscore > 1.
Week 8
Co-Primary Endpoint 2: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 52 in Week 8 Responders Per PMS - Maintenance Period
Time Frame: Week 52
The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ranked Secondary Endpoint 1: Percentage of Participants With Clinical Response Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period
Time Frame: Week 52
The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical response per FMS is defined as a decrease in FMS ≥ 3 points and ≥ 30% from Baseline.
Week 52
Ranked Secondary Endpoint 2: Percentage of Participants With Mucosal Healing at Week 52 in Week 8 Responders Per PMS - Maintenance Period
Time Frame: Week 52
The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those participants with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Mucosal healing per Mayo endoscopy subscore is defined as a subscore of ≤ 1.
Week 52
Ranked Secondary Endpoint 3: Percentage of Participants With Clinical Remission Per FMS at Week 52 in Week 8 Remitters Per PMS - Maintenance Period
Time Frame: Week 52
The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS remitters are defined as those participants with a PMS ≤ 2 and no individual subscore > 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
Week 52
Ranked Secondary Endpoint 4: Percentage of Participants With Corticosteroid-Free Clinical Remission Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period
Time Frame: Week 52
The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from baseline. Among participants receiving systemic corticosteroids at Baseline, corticosteroid-free clinical remission per FMS at Week 52 is defined as having discontinued systemic corticosteroids prior to Week 52 and being in FMS clinical remission at Week 52 (defined as Mayo Score ≤ 2 and no individual subscore > 1).
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 7, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M11-290
  • 2013-003032-77 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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