Study of Daxdilimab (HZN-7734) in Patients With Moderate-to-Severe Primary Discoid Lupus Erythematosus (RECAST DLE)

April 24, 2024 updated by: Horizon Therapeutics Ireland DAC

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Investigate the Efficacy and Safety of Daxdilimab Subcutaneous Injection in Reducing Disease Activity in Adult Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus

A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to-severe active primary Discoid Lupus Erythematosus (DLE) refractory to standard of care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Approximately 99 participants will be enrolled to receive daxdilimab or placebo administered subcutaneously once every four weeks (Q4W) from Day 1 to Week 44. After week 24 all subjects will be receiving daxbilimab, including those assigned to the placebo arm, Q4W from Week 24 to Week 44. The maximum trial duration per participant is approximately 60 weeks including screening, the 48 weeks for the treatment period where participants will receive daxdilimab or placebo, and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.

Study Type

Interventional

Enrollment (Estimated)

99

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1061AAS
        • Recruiting
        • CIPREC
        • Contact:
        • Principal Investigator:
          • Tania Zarowsky
    • Mendoza
      • Ciudad de Mendoza, Mendoza, Argentina, CP5500
        • Recruiting
        • Fundacion Scherbovsky
        • Contact:
        • Principal Investigator:
          • Maria Eugenia Caram
  • Brazil
      • São Paulo, Brazil, 01223-001
        • Recruiting
        • IPITEC Instituto de Pesquisa Inovação Tecnológica
        • Contact:
        • Principal Investigator:
          • Karine Simone Polonio
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-275
        • Recruiting
        • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
        • Contact:
        • Principal Investigator:
          • Xinaida Lima
    • Paraná
      • Água Verde, Paraná, Brazil, 80240-220
        • Recruiting
        • Hospital Universitário Evangélico Mackenzie
        • Contact:
        • Principal Investigator:
          • Lincoln Helder Zambaldi Fabricio
    • Preto Sao Paulo
      • Sao Jose Rio, Preto Sao Paulo, Brazil, 15090-000
        • Recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto, CIP - Centro Integrado de Pesquisa
        • Contact:
        • Principal Investigator:
          • Joao Roberto Antonio
    • Rio Do Janeiro
      • Niteroi, Rio Do Janeiro, Brazil, 24020-076
        • Recruiting
        • Complexo Hospitalar de Niteroi
        • Contact:
        • Principal Investigator:
          • Violeta Tortelly
      • Rio de Janeiro, Rio Do Janeiro, Brazil, 20241-180
        • Recruiting
        • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
        • Principal Investigator:
          • Jaqueline Barbeito de Vasconcellos
        • Contact:
    • Rio Grande Do Sul
      • Caxias do Sul, Rio Grande Do Sul, Brazil, 95070-560
        • Recruiting
        • Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde da Universidade de Caxias do Sul
        • Contact:
          • Daniela Wendt
          • Phone Number: +55 54 32182552
          • Email: dwendt@ucs.br
        • Principal Investigator:
          • Taciana Cappelletti
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
        • Recruiting
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
        • Contact:
        • Principal Investigator:
          • Magda Blessmann Weber
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
        • Recruiting
        • Hospital Moinhos de Vento
        • Contact:
        • Principal Investigator:
          • Andre' Vicente Esteves de Carvalho
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
        • Recruiting
        • LMK Serviços Médicos S/S
        • Contact:
        • Principal Investigator:
          • Paula Berenhauser D Elia
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13083-888
        • Recruiting
        • Universidade Estadual De Campinas
        • Contact:
        • Principal Investigator:
          • Magalhães Renata Ferreira
      • Santo André, Sao Paulo, Brazil, 09030-010
        • Recruiting
        • Hospital Christovão da Gama - Centro de Estudos
        • Principal Investigator:
          • Andréia Castanheiro da Costa
        • Contact:
      • São Bernardo Do Campo, Sao Paulo, Brazil, 09715
        • Recruiting
        • Centro Multidisciplinar de Estudos Clinicos
        • Principal Investigator:
          • Paulo Criado, MD
        • Contact:
      • Tatuí, Sao Paulo, Brazil, 18270-170
        • Recruiting
        • IMC - Instituto de Moléstias Cardiovasculares Tatui
        • Contact:
        • Principal Investigator:
          • Célia Pires
  • Bulgaria
      • Haskovo, Bulgaria, 6300
        • Recruiting
        • Dcc 'Sveti Georgi' Eood
        • Principal Investigator:
          • Irida Vasileva
        • Contact:
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Ambulatory for specialized medical care - individual practice for specialized medical care - skin and venereal diseases
        • Principal Investigator:
          • Ivan Botev, MD
        • Contact:
      • Sofia, Bulgaria, 1431
        • Recruiting
        • DCC "Alexandrovska" EOOD
        • Principal Investigator:
          • Snejina Vassileva
        • Contact:
      • Sofia, Bulgaria, 1606
        • Recruiting
        • Medical Center Eurohealth EOOD
        • Contact:
        • Principal Investigator:
          • Valentina Broshtilova-Nikolova
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C3
        • Recruiting
        • Alberta DermaSurgery Centre
        • Contact:
        • Principal Investigator:
          • Jaggi Rao, MD
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Recruiting
        • Brunswick Dermatology Center
        • Contact:
        • Principal Investigator:
          • Irina Turchin
    • Ontario
      • London, Ontario, Canada, N6H 5L5
        • Recruiting
        • Dermeffects
        • Contact:
        • Principal Investigator:
          • Wei Loo
      • Toronto, Ontario, Canada, M2N 3A6
        • Recruiting
        • North York Research, Inc
        • Contact:
        • Principal Investigator:
          • Firouzeh Niakosari, MD
      • Waterloo, Ontario, Canada, N2J 1C4
        • Not yet recruiting
        • K. Papp Clinical Research
        • Principal Investigator:
          • Ajith Cy, MD
        • Contact:
  • Czechia
      • Brno, Czechia, 602 00
        • Recruiting
        • Fakultni nemocnice u sv. Anny v Brne
        • Contact:
        • Principal Investigator:
          • Hana Jedlickova
      • Praha 1, Czechia, 110 00
        • Recruiting
        • Sanatorium Profesora Arenbergera
        • Principal Investigator:
          • Petr Arenberger
        • Contact:
  • Denmark
      • Copenhagen NV, Denmark, 2400
        • Recruiting
        • Bispebjerg Hospital, Dermato-Venerologisk Afdeling Og Videncenter for Sårheling, D/S.
        • Principal Investigator:
          • Mette Mogensen, MD
        • Contact:
      • Odense C, Denmark, 5000
        • Recruiting
        • OUH
        • Contact:
        • Principal Investigator:
          • Line Iversen
      • Roskilde, Denmark, 4000
        • Recruiting
        • Sjællands Universitetshospital
        • Principal Investigator:
          • Gregor Jemec, MD
        • Contact:
  • France
      • Lyon, France, 69003
        • Recruiting
        • Hopital Edouard Herriot - CHU Lyon
        • Principal Investigator:
          • Cecile Lesort
        • Contact:
      • Poitiers Cedex, France, 86021
        • Recruiting
        • CHU Poitiers - Hôpital la Milétrie
        • Contact:
        • Principal Investigator:
          • Ewa Hainaut
      • Rouen, France, 76031
        • Recruiting
        • CHU de Rouen - Hôpital Charles Nicolle
        • Contact:
        • Principal Investigator:
          • Anne-Benedicte Duval-Modeste
    • Maritimes
      • Nice Alpes, Maritimes, France, 6200
        • Recruiting
        • Service de dermatologie, hôpital Archet 2, CHU NICE
        • Principal Investigator:
          • Thierry Passeron
        • Contact:
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité - Universitätsmedizin Berlin
        • Principal Investigator:
          • Margitta Worm
        • Contact:
    • Baden Wuerttemberg
      • Tuebingen, Baden Wuerttemberg, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen
        • Contact:
        • Principal Investigator:
          • Matthias Hahn
    • Brandenburg
      • Falkensee, Brandenburg, Germany, 14612
        • Recruiting
        • BAG Dr. Freitag und Knöll
        • Contact:
        • Principal Investigator:
          • Lars Freitag
    • Niedersachsen
      • Oldenburg, Niedersachsen, Germany, 26133
        • Recruiting
        • Klinikum Oldenburg AöR
        • Principal Investigator:
          • Nikolaos Patsinakidis
        • Contact:
    • Rheinland Pfalz
      • Mainz, Rheinland Pfalz, Germany, 55131
        • Recruiting
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
        • Principal Investigator:
          • Petra Staubach-Renz
        • Contact:
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie
        • Principal Investigator:
          • Claudia Guenther
        • Contact:
  • Greece
      • Athens, Greece, 10676
        • Recruiting
        • General Hospital of Athens "Evangelismos"
        • Principal Investigator:
          • Aikaterini Malouchou
        • Contact:
      • Athens, Greece, 16121
        • Recruiting
        • Andreas Syggros Hospital
        • Principal Investigator:
          • Alexandros Stratigos
        • Contact:
      • Athens, Greece, 12462
        • Recruiting
        • University General Hospital "Attikon"
        • Principal Investigator:
          • Evangelia Papadavid
        • Contact:
      • Athens, Greece, 11525
        • Recruiting
        • 401 General Military Hospital of Athens
        • Contact:
        • Principal Investigator:
          • Markos Papakonstantis
      • Larissa, Greece, 41110
        • Recruiting
        • University General Hospital of Larissa
        • Contact:
        • Principal Investigator:
          • Angeliki-Victoria Roussaki-Schulze
      • Thessaloniki, Greece, 56429
        • Recruiting
        • General Hospital Papageorgiou
        • Principal Investigator:
          • Elisavet Lazaridou
        • Contact:
  • Poland
      • Krakow, Poland, 30-002
        • Recruiting
        • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Pawel Brzewski Spolka Cywilna
        • Principal Investigator:
          • Pawel Brzewski
        • Contact:
      • Malbork, Poland, 82-200
        • Recruiting
        • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
        • Contact:
        • Principal Investigator:
          • Anna Sobieszek-Kundro
      • Rzeszów, Poland, 35-055
        • Recruiting
        • Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina
        • Principal Investigator:
          • Adam Reich
        • Contact:
      • Szczecin, Poland, 70-332
        • Recruiting
        • LASER CLINIC S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki
        • Principal Investigator:
          • Katarzyna Turek-Urasinska
        • Contact:
      • Warszawa, Poland, 01-142
        • Recruiting
        • Clinical Research Group Sp. z o.o.
        • Principal Investigator:
          • Kamila Padlewska
        • Contact:
      • Warszawa, Poland, 02-807
        • Recruiting
        • Centralny Szpital Kliniczny Mswia
        • Principal Investigator:
          • Irena Walecka-Herniczek
        • Contact:
  • United States
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Recruiting
        • Arkansas Research Trials
        • Principal Investigator:
          • Scott Dinehart, MD
        • Contact:
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Wallace Medical Group
        • Contact:
        • Principal Investigator:
          • Paul Wallace, MD
      • Fremont, California, United States, 94538
        • Recruiting
        • The Center for Dermatology Clinical Research
        • Principal Investigator:
          • Sunil Dhawan, MD
        • Contact:
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Clinical Science Institute
        • Contact:
        • Principal Investigator:
          • Paul Yamauchi, MD
    • Florida
      • Miami, Florida, United States, 33173
        • Recruiting
        • Miami Dermatology & Laser Research
        • Principal Investigator:
          • Jill Waibel, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Dawes Fretzin Clinical Research Group, LLC
        • Contact:
        • Principal Investigator:
          • Scott Fretzin, MD
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
      • Waterford, Michigan, United States, 48328
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Recruiting
        • Minnesota Clinical Study Center
        • Contact:
        • Principal Investigator:
          • Steven Kempers, MD
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Medisearch Clinical Trials
        • Contact:
        • Principal Investigator:
          • Melody Stone, MD
    • New York
      • Forest Hills, New York, United States, 11375
        • Recruiting
        • Forest Hills Dermatology
        • Contact:
        • Principal Investigator:
          • Jeffery Weinberg, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Contact:
        • Principal Investigator:
          • Abraham Korman, MD
      • Fairborn, Ohio, United States, 45324
        • Recruiting
        • Wright State Physicians
        • Contact:
        • Principal Investigator:
          • Jeffrey Travers, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Recruiting
        • Paddington Testing Company, Inc.
        • Contact:
        • Principal Investigator:
          • Jennifer Parish, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Autoimmune Skin Diseases Unit, Dept. of Dermatology
        • Principal Investigator:
          • Victoria Werth, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77065
        • Recruiting
        • Center for Clinical Studies (Cypress)
        • Contact:
        • Principal Investigator:
          • Lauren Campbell, MD

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Willing and able to understand and provide written informed consent.
  • Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.

  • A diagnosis of discoid lupus erythematosus for ≥ 6 months prior to screening supported by a history of:

    1. A biopsy or
    2. a clinical feature score of ≥ 7 on the DLE Classification Criteria (DLECC) scale

  • Currently active discoid lupus with all the following

    1. Digital photography adjudicated with central reading to confirm a currently active discoid disease lesion.
    2. CLASI-A score ≥ 8 related to discoid lesions at Baseline
  • Treatment refractory DLE defined as active disease despite current or historical treatment with a systemic treatment.
  • Females are eligible to participate if they are not pregnant or breastfeeding, and meet the contraceptive/barrier requirement(s).
  • Males are eligible to participate if they agree to the contraceptive/barrier requirement(s).
  • Vaccination status should be up to date per local standards.

Key Exclusion Criteria:

  • Participation in another clinical study with an investigational drug within 4 weeks prior to Randomization or within 5 published half-lives, whichever is longer.
  • Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product (IP) or interpretation of participant safety or trial results.
  • Weight > 160 kg (352 pounds) at Screening.
  • History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous monoclonal antibody (mAb) or human immunoglobin (Ig) therapy.
  • Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the informed consent form (ICF) through 6 months after receiving the last dose of IP.
  • Splenectomy
  • Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to screening through randomization.
  • History of clinically significant cardiac disease including unstable angina, myocardial infarction, congestive heart failure within 6 months prior to Randomization; arrhythmia requiring active therapy, except for clinically insignificant extra systoles, or minor conduction abnormalities.

  • History of cancer within the past 5 years, except as follows:

    • In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to Screening, or
    • Cutaneous basal cell or squamous cell carcinoma treated with curative therapy.
  • Any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection.
  • Known history of a primary immunodeficiency or an underlying condition, such as known human immunodeficiency virus (HIV) infection, or a positive result for HIV infection per central laboratory.
  • Participants with positive hepatitis B serologic test results.
  • All participants will undergo testing for hepatitis C antibody (HCVAb) during Screening.
  • Participants who are HCVAb positive will be reflex tested for hepatitis C virus (HCV) RNA and if HCV RNA is positive, the participant is not eligible for the study.
  • Active tuberculosis (TB), or a positive interferon-gamma release assay (IGRA) test at screening, unless documented history of appropriate treatment for active or latent TB.

Participants with an indeterminate IGRA test result can repeat the test, but if the repeat test is also indeterminate, they will be excluded.

  • Any severe herpes virus family infection (including Epstein-Barr virus, cytomegalovirus (CMV)) at any time prior to Randomization, including, but not limited to, disseminated herpes, herpes encephalitis, recent recurrent herpes zoster (defined as 2 episodes within the last 2 years), or ophthalmic herpes.
  • Any herpes zoster, cytomegalovirus (CMV), or Epstein-Barr virus infection that was not completely resolved 12 weeks prior to Randomization.
  • Opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within 2 years prior to Randomization.
  • Any acute illness or evidence of clinically significant active infection on Day 1.
  • Participants who have COVID-19 or other significant infection, or in the judgment of the Investigator, may be at a high risk of COVID-19 or its complications should not be randomized.
  • Systemic lupus erythematosus defined by fulfilling 2020 American College of Rheumatology/European Alliance of Associations for Rheumatology criteria for systemic lupus erythematosus (SLE).
  • Current diagnosis of a systemic connective tissue disease.
  • Current inflammatory skin disease other than DLE, that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments and confound the disease activity assessments.
  • Exposure to an experimental drug either 30 days, 5 half-lives of the agent, or twice the duration of the biological effect of the agent, whichever is longer, prior to Randomization and through the final trial visit.
  • Receipt of a live-attenuated vaccine within 4 weeks prior to Randomization.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo/Daxdilimab Arm 1
Administration of placebo Q4W from Day 1 through Week 20 and administration of Daxdilimab Q4W from Week 24 through Week 44.
Drug: Placebo/Daxdilimab
Placebo/Daxdilimab will be administered subcutaneously as two injections for each dose.
Experimental: Daxdilimab Arm 2
Administration of Daxdilimab Q4W from Day 1 through Week 44.
Drug: Daxdilimab
Daxdilimab will be administered subcutaneously as two injections for each dose.
Other Names:
  • HZN-7734
Experimental: Daxdilimab Arm 3
Administration of Daxdilimab Q4W from Day 1 through Week 44.
Drug: Daxdilimab
Daxdilimab will be administered subcutaneously as two injections for each dose.
Other Names:
  • HZN-7734

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in Cutaneous Lupus Erythematosus Disease and Severity Index-Activity (CLASI-A) score from Baseline to Week 24.
Time Frame: Day 1 to Week 24
Day 1 to Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants who achieve 0 or 1 on the Cutaneous Lupus Activity-Investigator's Global Assessment (CLA-IGA) scale at Week 24 (5-point Likert scale [0-4]).
Time Frame: Day 1 to Week 24
Day 1 to Week 24
Proportion of participants who achieve a ≥ 50% reduction in Cutaneous Lupus Erythematosus Disease and Severity Index-Activity (CLASI-A) score from Baseline (Day 1) at Week 24.
Time Frame: Day 1 to Week 24
Day 1 to Week 24
Mean change in the Score of Activity and Damage in Discoid Lupus Erythematosus (SADDLE) from Baseline (Day 1) to Week 24 patients with primary DLE.
Time Frame: Day 1 to Week 24
Day 1 to Week 24
Serum concentration of daxdilimab over time.
Time Frame: Day 1 to Week 48
Day 1 to Week 48
Anti-Drug Antibody (ADA) rate.
Time Frame: Day 1 to Week 56
Day 1 to Week 56
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and treatment-emergent adverse events of special interest (TEAESIs).
Time Frame: Day 1 to Week 56
Day 1 to Week 56

Collaborators and Investigators

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

Sponsor

Horizon Therapeutics Ireland DAC

Investigators

  • Study Director: Medical Director, Horizon Therapeutics Ireland DAC

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)

October 12, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HZNP-DAX-202
  • 2022-000831-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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