Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
448 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-08-31
Study Completion Date
2012-06-30
Brief Summary
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The primary purpose of the study is to help answer the following research questions, and not to provide treatment for Rheumatoid Arthritis (RA):
* The safety of LY2439821 and any side effects that might be associated with it.
* Whether LY2439821 can help participants with active RA.
* How much LY2439821 should be given to participants.
* The safety of LY2439821 and any side effects that might be associated with it.
* Whether LY2439821 can help participants with active RA.
* How much LY2439821 should be given to participants.
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Detailed Description
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Study I1F-MC-RHAK is a multicenter study in participants with active RA on concomitant conventional DMARD therapy. The study is a Phase 2 study with 2 parts. Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging design and Part B is an optional, open-label extension design. Two participant populations will be evaluated in this study: bDMARD-naive participants and TNFα-IR participants. Participants in Part A receive multiple subcutaneous injections of LY2439821 \[bDMARD-naive participants: 0 (placebo), 3, 10, 30, 80, or 180 mg; TNFα-IR participants: 0 (placebo), 80 or 180 mg\] at Weeks 0, 1, 2, 4, 6, 8, and 10. Participants in Part B receive subcutaneous injections of LY2439821 160 mg at Weeks 16, 18, and 20, and every 4 weeks thereafter through Week 60. Participants who complete both Part A and B have a total study participation of up to approximately 72 to 84 weeks.
Conditions
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Rheumatoid Arthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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3 mg LY2439821 (bDMARD-naive population)
3 milligrams (mg) LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. \[Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)\]
Group Type
EXPERIMENTAL
LY2439821
Intervention Type
BIOLOGICAL
Subcutaneous
10 mg LY2439821 (bDMARD-naive population)
10 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Group Type
EXPERIMENTAL
LY2439821
Intervention Type
BIOLOGICAL
Subcutaneous
30 mg LY2439821 (bDMARD-naive population)
30 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Group Type
EXPERIMENTAL
LY2439821
Intervention Type
BIOLOGICAL
Subcutaneous
80 mg LY2439821 (bDMARD-naive population)
80 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Group Type
EXPERIMENTAL
LY2439821
Intervention Type
BIOLOGICAL
Subcutaneous
180 mg LY2439821 (bDMARD-naive population)
180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Group Type
EXPERIMENTAL
LY2439821
Intervention Type
BIOLOGICAL
Subcutaneous
80 mg LY2439821 (TNFa-IR population)
80 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. \[Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)\]
Group Type
EXPERIMENTAL
LY2439821
Intervention Type
BIOLOGICAL
Subcutaneous
180 mg LY2439821 (TNFa-IR population)
180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Group Type
EXPERIMENTAL
LY2439821
Intervention Type
BIOLOGICAL
Subcutaneous
Placebo (bDMARD-naive population)
Placebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Subcutaneous
Placebo (TNFa-IR population)
Placebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Subcutaneous
Interventions
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LY2439821
Subcutaneous
Intervention Type
BIOLOGICAL
Placebo
Subcutaneous
Intervention Type
DRUG
Other Intervention Names
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ixekizumab
Eligibility Criteria
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Inclusion Criteria
* You must be between the ages of 18 and 75
* You must have active RA
Qualifications Specific to the bDMARD-naive Population:
You must be regularly using methotrexate (MTX) for at least 12 weeks before your participation in this study
Qualifications Specific to the TNFα-IR Population:
* You must have been treated with at least 1 biologic TNFα inhibitor therapy and either had an insufficient response to at least 3 months of treatment OR have been intolerant of such treatment
* You must be regularly using at least 1 conventional DMARD in a stable treatment regimen
* You must have active RA
Qualifications Specific to the bDMARD-naive Population:
You must be regularly using methotrexate (MTX) for at least 12 weeks before your participation in this study
Qualifications Specific to the TNFα-IR Population:
* You must have been treated with at least 1 biologic TNFα inhibitor therapy and either had an insufficient response to at least 3 months of treatment OR have been intolerant of such treatment
* You must be regularly using at least 1 conventional DMARD in a stable treatment regimen
Exclusion Criteria
* You are concomitantly using non-steroidal anti-inflammatory drugs (NSAIDS), unless you are on a stable dose within the last 2 weeks
* You are a woman who is lactating or breast feeding
* You have donated more than 300 milliliters (mL) of blood within the last month
* You have received glucocorticoid administered by intra-articular, intramuscular, or intravenous injection or oral corticosteroids at an average daily dose of greater than 10 mg per day of prednisone or its equivalent within the last 4 weeks
* You had surgery on a joint that is to be assessed in the study within 2 months of study enrollment, or will require such during the study
* You have another serious disorder or illness
* You suffered a serious bacterial infection (for example, pneumonia, cellulitis, or bone or joint infections) within the last 3 months
* You have a history of uncontrolled high blood pressure
* You have clinical laboratory test results at entry that are outside the normal reference range
* You are an employee of the clinic or you are an immediate family member of an employee of the clinic. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
* You are currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug
* If you are a woman and you could become pregnant during this study, you must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study.
* If you are a post-menopausal woman, you must be at least 45 years of age and have not menstruated for the last 12 months
* If you are a post-menopausal woman between 40 and 45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, you must have an additional blood test to see if you can participate.
* If you are male, you must agree to reduce the risk of your female partner becoming pregnant during the study.
Exclusions Specific to the bDMARD-naive Population:
* You have received any prior bDMARD therapy such as TNFα, Interleukin (IL)-1, IL-6, T-cell, or B-cell targeted therapies
* You have had an inadequate response to a minimum of 3 months of treatment with 5 or more conventional DMARDs \[such as leflunomide, azathioprine, cyclosporine, etcetera (etc.)\]
* You have used DMARDs other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
* You have used leflunomide within the last 12 weeks and have not received cholestyramine to speed up the elimination of leflunomide from your body.
Exclusions Specific to the TNFα-IR Population:
* You are currently using or recently used a bDMARD or a biologic TNFα inhibitor therapy within specified periods
* You have had a serious reaction to other biologic DMARDs that, in the study doctor's opinion, puts you at serious risk
* You have used cyclosporine or any other immunosuppressive in the 8 weeks before your participation in this study
* You are a woman who is lactating or breast feeding
* You have donated more than 300 milliliters (mL) of blood within the last month
* You have received glucocorticoid administered by intra-articular, intramuscular, or intravenous injection or oral corticosteroids at an average daily dose of greater than 10 mg per day of prednisone or its equivalent within the last 4 weeks
* You had surgery on a joint that is to be assessed in the study within 2 months of study enrollment, or will require such during the study
* You have another serious disorder or illness
* You suffered a serious bacterial infection (for example, pneumonia, cellulitis, or bone or joint infections) within the last 3 months
* You have a history of uncontrolled high blood pressure
* You have clinical laboratory test results at entry that are outside the normal reference range
* You are an employee of the clinic or you are an immediate family member of an employee of the clinic. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
* You are currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug
* If you are a woman and you could become pregnant during this study, you must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study.
* If you are a post-menopausal woman, you must be at least 45 years of age and have not menstruated for the last 12 months
* If you are a post-menopausal woman between 40 and 45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, you must have an additional blood test to see if you can participate.
* If you are male, you must agree to reduce the risk of your female partner becoming pregnant during the study.
Exclusions Specific to the bDMARD-naive Population:
* You have received any prior bDMARD therapy such as TNFα, Interleukin (IL)-1, IL-6, T-cell, or B-cell targeted therapies
* You have had an inadequate response to a minimum of 3 months of treatment with 5 or more conventional DMARDs \[such as leflunomide, azathioprine, cyclosporine, etcetera (etc.)\]
* You have used DMARDs other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
* You have used leflunomide within the last 12 weeks and have not received cholestyramine to speed up the elimination of leflunomide from your body.
Exclusions Specific to the TNFα-IR Population:
* You are currently using or recently used a bDMARD or a biologic TNFα inhibitor therapy within specified periods
* You have had a serious reaction to other biologic DMARDs that, in the study doctor's opinion, puts you at serious risk
* You have used cyclosporine or any other immunosuppressive in the 8 weeks before your participation in this study
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT-5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Peoria, Arizona, United States
Site Status
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La Mesa, California, United States
Site Status
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Palm Desert, California, United States
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San Jose, California, United States
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Santa Maria, California, United States
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Stanford, California, United States
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Westlake Village, California, United States
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Denver, Colorado, United States
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Washington D.C., District of Columbia, United States
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Lake Mary, Florida, United States
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Melbourne, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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Decatur, Georgia, United States
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Rome, Georgia, United States
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Idaho Falls, Idaho, United States
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Springfield, Illinois, United States
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Cumberland, Maryland, United States
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Frederick, Maryland, United States
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Wheaton, Maryland, United States
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Bingham Farms, Michigan, United States
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St Louis, Missouri, United States
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Wilmington, North Carolina, United States
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Tulsa, Oklahoma, United States
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Bethlehem, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Sugar Land, Texas, United States
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Temple, Texas, United States
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Salt Lake City, Utah, United States
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Arlington, Virginia, United States
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Olympia, Washington, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, , Argentina
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Quilmes, , Argentina
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San Juan, , Argentina
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San Miguel de Tucumán, , Argentina
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Santiago, , Chile
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Hohenfelde, , Germany
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Tübingen, , Germany
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Bangalore, , India
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Hyderabaad, , India
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Jaipur, , India
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Secunderabad, , India
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Arequipa, , Peru
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Lima, , Peru
Site Status
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Pueblo Libre, , Peru
Site Status
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Bytom, , Poland
Site Status
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Częstochowa, , Poland
Site Status
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Gmina Końskie, , Poland
Site Status
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Kościan, , Poland
Site Status
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Krakow, , Poland
Site Status
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Poznan, , Poland
Site Status
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Torun, , Poland
Site Status
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Warsaw, , Poland
Site Status
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Baia Mare, , Romania
Site Status
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Bucharest, , Romania
Site Status
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Cluj-Napoca, , Romania
Site Status
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Iași, , Romania
Site Status
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Moscow, , Russia
Site Status
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Saint Petersburg, , Russia
Site Status
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Daejeon, , South Korea
Site Status
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Pusan, , South Korea
Site Status
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Seoul, , South Korea
Site Status
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Kaohsiung County, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Taipei, , Taiwan
Site Status
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Taoyuan District, , Taiwan
Site Status
Countries
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United States
Argentina
Chile
Germany
India
Peru
Poland
Romania
Russia
South Korea
Taiwan
References
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Genovese MC, Braun DK, Erickson JS, Berclaz PY, Banerjee S, Heffernan MP, Carlier H. Safety and Efficacy of Open-label Subcutaneous Ixekizumab Treatment for 48 Weeks in a Phase II Study in Biologic-naive and TNF-IR Patients with Rheumatoid Arthritis. J Rheumatol. 2016 Feb;43(2):289-97. doi: 10.3899/jrheum.140831. Epub 2015 Dec 15.
Reference Type
DERIVED
Genovese MC, Greenwald M, Cho CS, Berman A, Jin L, Cameron GS, Benichou O, Xie L, Braun D, Berclaz PY, Banerjee S. A phase II randomized study of subcutaneous ixekizumab, an anti-interleukin-17 monoclonal antibody, in rheumatoid arthritis patients who were naive to biologic agents or had an inadequate response to tumor necrosis factor inhibitors. Arthritis Rheumatol. 2014 Jul;66(7):1693-704. doi: 10.1002/art.38617.
Reference Type
DERIVED
Other Identifiers
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I1F-MC-RHAK
Identifier Type: OTHER
Identifier Source: secondary_id
12061
Identifier Type: -
Identifier Source: org_study_id
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