Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)

Last updated: September 11, 2025
Sponsor: Arthrosi Therapeutics
Overall Status: Active - Not Recruiting

Phase

3

Condition

Joint Injuries

Collagen Vascular Diseases

Gout (Hyperuricemia)

Treatment

AR882 75 mg

AR882 50 mg

Placebo

Clinical Study ID

NCT06846515
AR882-301
  • Ages 18-85
  • All Genders

Study Summary

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of gout

  • Occurrence of ≥ 2 self-reported gout flares in the last 12 months

  • Body weight no less than 50 kg

  • Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA ≥ 7mg/dL

  • Patients who are on medically appropriate ULT must have sUA > 6 mg/dL

  • Serum creatinine must be < 3.0 mg/dL and estimated CLcr ≥ 30 mL/min

Exclusion

Exclusion Criteria:

  • Malignancy within 5 years, except for successfully treated basal or squamous cellcarcinoma of the skin

  • Pregnant or breastfeeding

  • History of symptomatic kidney stones within the past 6 months

Study Design

Total Participants: 750
Treatment Group(s): 3
Primary Treatment: AR882 75 mg
Phase: 3
Study Start date:
March 11, 2025
Estimated Completion Date:
April 30, 2026

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  • Arthrosi Investigative Site (620)

    Birmingham, Alabama 35215
    United States

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  • Arthrosi Investigative Site (616)

    Huntsville, Alabama 35801
    United States

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  • Arthrosi Investigative Site (620)

    Birmingham 4049979, Alabama 4829764 35215
    United States

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  • Arthrosi Investigative Site (616)

    Huntsville 4068590, Alabama 4829764 35801
    United States

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  • Arthrosi Investigative Site (629)

    Chandler, Arizona 85225
    United States

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  • Arthrosi Investigative Site (680)

    Peoria, Arizona 85381
    United States

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  • Arthrosi Investigative Site (640)

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Arthrosi Investigative Site (680)

    Peoria 5308480, Arizona 5551752 85381
    United States

    Site Not Available

  • Arthrosi Investigative Site (640)

    Phoenix 5308655, Arizona 5551752 85018
    United States

    Site Not Available

  • Arthrosi Investigative Site (617)

    Little Rock, Arkansas 72205
    United States

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  • Arthrosi Investigative Site (617)

    Little Rock 4119403, Arkansas 4099753 72205
    United States

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  • Arthrosi Investigative Site (614)

    Garden Grove, California 92844
    United States

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  • Arthrosi Investigative Site (618)

    La Mesa, California 91942
    United States

    Active - Recruiting

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    La Mesa, California 91942
    United States

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    La Palma, California 90623
    United States

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  • Arthrosi Investigative Site (632)

    Lincoln, California 95648
    United States

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    Lomita, California 90717
    United States

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  • Arthrosi Investigative Site (675)

    Long Beach, California 90806
    United States

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  • Arthrosi Investigative Site (603)

    Santa Monica, California 90404
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  • Arthrosi Investigative Site (672)

    Tarzana, California 91356
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    Thousand Oaks, California 91360
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    Tujunga, California 91042
    United States

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  • Arthrosi Investigative Site (667)

    Whittier, California 90602
    United States

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    Garden Grove 5351515, California 5332921 92844
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    La Mesa 5363990, California 5332921 91942
    United States

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    La Mesa 5363990, California 5332921 91942
    United States

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  • Arthrosi Investigative Site (655)

    La Palma 5364022, California 5332921 90623
    United States

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    Lincoln 5366375, California 5332921 95648
    United States

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  • Arthrosi Investigative Site (605)

    Lomita 5367767, California 5332921 90717
    United States

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  • Arthrosi Investigative Site (675)

    Long Beach 5367929, California 5332921 90806
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    Santa Monica 5393212, California 5332921 90404
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  • Arthrosi Investigative Site (672)

    Tarzana 5401143, California 5332921 91356
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    Thousand Oaks 5402405, California 5332921 91360
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    Aurora, Colorado 80012
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    Colorado Springs, Colorado 80909
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    Fort Collins, Colorado 80528
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    Aurora 5412347, Colorado 5417618 80012
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    Colorado Springs 5417598, Colorado 5417618 80909
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    Fort Collins 5577147, Colorado 5417618 80528
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    Cooper City, Florida 33024
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    Miami, Florida 33173
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    Miami, Florida 33176
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    Palmetto Bay, Florida 33157
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    Sanford, Florida 32771
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    Tampa, Florida 33609
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    Jupiter 4160610, Florida 4155751 33458
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    Miami 4164138, Florida 4155751 33173
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    Miami 4164138, Florida 4155751 33176
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    Palmetto Bay 4167634, Florida 4155751 33157
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    Sanford 4172086, Florida 4155751 32771
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    Atlanta, Georgia 30329
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    Lilburn, Georgia 30047
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    Atlanta 4180439, Georgia 4197000 30329
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    Melrose Park, Illinois 60160
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    Chicago 4887398, Illinois 4896861 60602
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    Melrose Park 4901868, Illinois 4896861 60160
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    Indianapolis, Indiana 46202
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    Indianapolis 4259418, Indiana 4921868 46202
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    Overland Park, Kansas 66209
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    Overland Park 4276873, Kansas 4273857 66209
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    Louisville, Kentucky 40205
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    Louisville 4299276, Kentucky 6254925 40205
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    Mandeville, Louisiana 70471
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    New Orleans, Louisiana 70115
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    Prairieville, Louisiana 70769
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    Mandeville 4332455, Louisiana 4331987 70471
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    New Orleans 4335045, Louisiana 4331987 70115
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    Prairieville 4338012, Louisiana 4331987 70769
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    Oxon Hill, Maryland 20745
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    Rockville, Maryland 20852
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    Oxon Hill 4364759, Maryland 4361885 20745
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    Rockville 4367175, Maryland 4361885 20852
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    Fall River, Massachusetts 02721
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    Fall River 4936159, Massachusetts 6254926 02721
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    Bay City, Michigan 48706
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    Farmington Hills, Michigan 48334
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    Southfield, Michigan 48076
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    Bay City 4985180, Michigan 5001836 48706
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    Farmington Hills 4992523, Michigan 5001836 48334
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    Southfield 5010636, Michigan 5001836 48076
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    Gulfport, Mississippi 39503
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    Jackson, Mississippi 39202
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    Olive Branch, Mississippi 38654
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    Gulfport 4428667, Mississippi 4436296 39503
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    Jackson 4431410, Mississippi 4436296 39202
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    Olive Branch 4439869, Mississippi 4436296 38654
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    Springfield, Missouri 65807
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    Town and Country, Missouri 63017
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    Springfield 4409896, Missouri 4398678 65807
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    Town and Country 4411912, Missouri 4398678 63017
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    Missoula, Montana 59808
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    Missoula 5666639, Montana 5667009 59808
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    Lincoln, Nebraska 68516
    United States

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    Omaha, Nebraska 68144
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    Omaha, Nebraska 68114
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    Lincoln 5072006, Nebraska 5073708 68516
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    Omaha 5074472, Nebraska 5073708 68144
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    Omaha 5074472, Nebraska 5073708 68114
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    Las Vegas, Nevada 89102
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    Las Vegas 5506956, Nevada 5509151 89102
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    Brooklyn, New York 11215
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    Hartsdale, New York 10530
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    Brooklyn 5110302, New York 5128638 11215
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    Hartsdale 5120141, New York 5128638 10530
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    Charlotte, North Carolina 28207
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    Charlotte, North Carolina 28277
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    Raleigh, North Carolina 27607
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    Shelby, North Carolina 28150
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    Charlotte 4460243, North Carolina 4482348 28207
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    Charlotte 4460243, North Carolina 4482348 28277
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    Raleigh 4487042, North Carolina 4482348 27607
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    Fargo, North Dakota 58104
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    Fargo 5059163, North Dakota 5690763 58104
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    Mason, Ohio 45040
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    Mason 4517698, Ohio 5165418 45040
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    Norman,, Oklahoma 73072
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    Tulsa, Oklahoma 74133
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    Norman 4543762, Oklahoma 4544379 73072
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    Horsham, Pennsylvania 19044
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    Philadelphia, Pennsylvania 19107
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    Horsham 5194302, Pennsylvania 6254927 19044
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    Philadelphia 4560349, Pennsylvania 6254927 19107
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    Charlston, South Carolina 29407
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    Fort Mill, South Carolina 29707
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    North Charleston, South Carolina 29405
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    Charleston 4574324, South Carolina 4597040 29407
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    Fort Mill 4578977, South Carolina 4597040 29707
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    North Charleston 4589387, South Carolina 4597040 29405
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    Chattanooga, Tennessee 37404
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    Hendersonville, Tennessee 37075
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    Chattanooga 4612862, Tennessee 4662168 37404
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    Hendersonville 4628735, Tennessee 4662168 37075
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    Amarillo, Texas 79106
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    Dallas, Texas 75251
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    Plano, Texas 75024
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    Prosper, Texas 75078
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    Sugar Land, Texas 77479
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    Tomball, Texas 77375
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    Tomball, Texas 77375
    United States

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    Amarillo 5516233, Texas 4736286 79106
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    Austin 4671654, Texas 4736286 78735
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    Dallas 4684888, Texas 4736286 75251
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    DeSoto 4685524, Texas 4736286 75115
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    Houston 4699066, Texas 4736286 77074
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    Plano 4719457, Texas 4736286 75024
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    Prosper 4720833, Texas 4736286 75078
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    Sugar Land 4734825, Texas 4736286 77479
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    Tomball 4737094, Texas 4736286 77375
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    Clinton, Utah 84015
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    Salt Lake City, Utah 84121
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    Salt Lake City, Utah 84124
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    Clinton 5773001, Utah 5549030 84015
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    Salt Lake City 5780993, Utah 5549030 84121
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    Salt Lake City 5780993, Utah 5549030 84124
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    Charlottesville, Virginia 29911
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    Winchester, Virginia 22601
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    Charlottesville 4752031, Virginia 6254928 29911
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    Winchester 4794120, Virginia 6254928 22601
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    Bellevue, Washington 98004
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    Bellevue 5786882, Washington 5815135 98004
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    Kenosha, Wisconsin 53144
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  • Arthrosi Investigative Site (668)

    Kenosha 5258393, Wisconsin 5279468 53144
    United States

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