Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis

Last updated: May 7, 2024
Sponsor: Bausch Health Americas, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Arginase Deficiency

Hepatic Encephalopathy

Neurologic Disorders

Treatment

Rifaximin SSD

Placebo

Clinical Study ID

NCT05297448
RNLC3132
  • Ages 18-85
  • All Genders

Study Summary

Study RNLC3132 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Diagnosis of liver cirrhosis with medically controlled ascites (>30 days) notrequiring therapeutic paracentesis (could have had paracentesis in the past).
  • Conn (West Haven Criteria) score of < 2.
  • Mini-Mental State Examination (MMSE) score > 24 at screening.
  • ≥ 18 and ≤ 85 years of age.

Exclusion

Key Exclusion Criteria:

  • Active COVID-19 that is unresolved
  • History of SBP
  • History of EVB or AKI-HRS within 6 months
  • History of OHE episode (Conn score ≥ 2)

Study Design

Total Participants: 466
Treatment Group(s): 2
Primary Treatment: Rifaximin SSD
Phase: 3
Study Start date:
August 03, 2022
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Bausch Site 709

    Camperdown, New South Wales 2050
    Australia

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  • Bausch Site 701

    Darlinghurst, New South Wales 2010
    Australia

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  • Bausch Site 700

    Kingswood, New South Wales 2747
    Australia

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  • Bausch Site 710

    Westmead, New South Wales 2145
    Australia

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    Box Hill, Victoria 3050
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  • Bausch Site 707

    Fitzroy, Victoria 3065
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  • Bausch Site 706

    Footscray, Victoria 3011
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  • Bausch Site 704

    Parkville, Victoria 3050
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  • Bausch Site 703

    Murdoch, Western Australia 6150
    Australia

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  • Bausch Site 705

    Perth, Western Australia 6000
    Australia

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  • Bausch Site 972

    Antwerpen, 2650
    Belgium

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  • Bausch Site 978

    Genk, 3600
    Belgium

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  • Bausch Site 973

    Gent, 9000
    Belgium

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  • Bausch Site 976

    Kortrijk, 8500
    Belgium

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  • Bausch Site 974

    Liege, 4000
    Belgium

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    Mechelen, 2800
    Belgium

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    Ruse, 7013
    Bulgaria

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    Sliven, 8800
    Bulgaria

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    Sofia, 1431
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    Sofia, 1606
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    Sofia, 1618
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    Stara Zagora, 6000
    Bulgaria

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  • Bausch Site Heritage Medical Research Clinic

    Calgary, Alberta T2N 4Z6
    Canada

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  • Bausch Site University of Alberta Hospital

    Edmonton, Alberta T6G 2B7
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    Vancouver, British Columbia V6Z 2K5
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    Barrie, Ontario L4M 7G1
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    Brampton, Ontario L6R 3J7
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    Hamilton, Ontario L8V 1C3
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    Toronto, Ontario M3M 0A9
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    Toronto, Ontario M5G 1N8
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    Waterloo, Ontario N2J 1C4
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    Montreal, Quebec H2L 4P9
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    Montreal, Quebec HSX 0A9
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    Quebec, G1V 4T3
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    Quebec, G1V 4T3
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    Angers, 49100
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    Belfort, 90015
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    Besançon, 25000
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    Clermont-Ferrand, 63003
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    Limoges, 87042
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    Lyon, 69004
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    Nice, 06200
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    Paris, 75013
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    Paris, 75014
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    Pessac, 33604
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    Rennes, 35033
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    Toulouse, 31059
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    Vandœuvre-lès-Nancy, 54500
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    Secunderabad, 500003
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    Sūrat, 395009
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    Milano, 20132
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    Napoli, 80131
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    Novara, 28100
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    Rozzano, 20089
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    Busan, 49241
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    Busan, 47392
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    Gangwon-do, 26426
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    Goyang-si, 10408
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    Gyeonggi-do, 15355
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    Gyeongsang, 50612
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    Seongnam-si, 13496
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    Seoul, 03080
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    Seoul, 06351
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    Seoul, 08308
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    Seoul, 06273
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    Seoul, 03312
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    Seoul, 01830
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    Seoul, 06591
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    Yongin-si, 16995
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    Ulaan Baatar, 14230
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    Grafton, 1023
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    Hamilton, 3240
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    Bydgoszcz, 85-605
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    Katowice, 40-752
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    Kraków, 30-721
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    Mysłowice, 41-400
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    Staszów, 28-200
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    Wrocław, 51-162
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    Wrocław, 50-220
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    Guaynabo, 00966
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    San Juan, 00907
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    Barcelona, 08035
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    Madrid, 28034
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    Málaga, 29010
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    Pontevedra, 36164
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    Valencia, 46010
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    Valencia, 46014
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    Zaragoza, 50009
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    Dundee, DD1 9SY
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    Hull, HU3 2JZ
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    Liverpool, L9 7AL
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    Nottingham, NG7 2UH
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    Plymouth, PL6 8DH
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    Homewood, Alabama 35209
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    Chandler, Arizona 85224
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    Chandler, Arizona 85224
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    Phoenix, Arizona 85013
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    Sun City, Arizona 85351
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    Tucson, Arizona 85715
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    Little Rock, Arkansas 77205
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    Bakersfield, California 93309
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    Coronado, California 92118
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    Covina, California 91722
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    Escondido, California 92025
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    Fresno, California 93701
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    Fresno, California 93720
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    Lancaster, California 93534
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    Long Beach, California 90808
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    Los Angeles, California 90067
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    Los Angeles, California 90095
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    Orange, California 92868
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    Redwood City, California 94063
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    Rialto, California 92377
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    San Bernardino, California 92408
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    San Diego, California 92114
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    Upland, California 91786
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    Valencia, California 91355
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    Colorado Springs, Colorado 80907
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    Bristol, Connecticut 06010
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    Doral, Florida 33122
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    Hialeah, Florida 33013
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    Hialeah, Florida 33012
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    Hialeah, Florida 33012
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    Hialeah, Florida 33016
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    Hollywood, Florida 33024
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    Inverness, Florida 34452
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    Miami, Florida 33126
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    Miami, Florida 33186
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    Miami, Florida 33175
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    Miami, Florida 33176
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    Miami, Florida 33134
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    Miami, Florida 33125
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    Miami, Florida 33144
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    Miami, Florida 23229
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    Miami, Florida 33032
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    Miami, Florida 33165
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    Miami, Florida 33165
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    Miami Lakes, Florida 33016
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    New Port Richey, Florida 34653
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    Ocala, Florida 34471
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    Ocala, Florida 34471
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    Ocoee, Florida 34761
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    Orange City, Florida 32763
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    Orlando, Florida 32808
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    Palmetto Bay, Florida 33157
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    Port Orange, Florida 32127
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    Wellington, Florida 33467
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    Weston, Florida 33331
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    Zephyrhills, Florida 33542
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    Macon, Georgia 31201
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    Chicago, Illinois 60612
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    Gurnee, Illinois 60031
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    Indianapolis, Indiana 46202
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    South Bend, Indiana 46635
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    Iowa City, Iowa 52242
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    West Des Moines, Iowa 50266
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    Topeka, Kansas 66606
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    Lafayette, Louisiana 70503
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    Marrero, Louisiana 70072
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    Metairie, Louisiana 70006
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    New Orleans, Louisiana 70125
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    New Orleans, Louisiana 70032
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    Shreveport, Louisiana 71105
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    Greenbelt, Maryland 20770
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    Boston, Massachusetts 02111
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    Detroit, Michigan 48202
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    Flowood, Mississippi 39232
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    Jackson, Mississippi 39216
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    Jefferson City, Missouri 65109
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    Saint Louis, Missouri 63104
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    Florham Park, New Jersey 07932
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    Freehold, New Jersey 07728
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    Newark, New Jersey 07103
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    Toms River, New Jersey 08755
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    Bronx, New York 10467
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    East Syracuse, New York 13057
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    New York, New York 10032
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    Asheville, North Carolina 28801
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    Durham, North Carolina 27710
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    High Point, North Carolina 27262
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    Monroe, North Carolina 28112
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    Smithfield, North Carolina 27577
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    Dayton, Ohio 45414
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    Liberty Township, Ohio 45044
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    Springboro, Ohio 45066
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    Westlake, Ohio 44145
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    Allentown, Pennsylvania 18104
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    Harrisburg, Pennsylvania 17110
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    Philadelphia, Pennsylvania 19104
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    Philadelphia, Pennsylvania 19104
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    Providence, Rhode Island 02905
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    Charleston, South Carolina 29425
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    Columbia, South Carolina 29204
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    Summerville, South Carolina 29486
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    Chattanooga, Tennessee 37421
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    Chattanooga, Tennessee 37421
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    Hermitage, Tennessee 37076
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    Union City, Tennessee 38261
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    Baytown, Texas 77523
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    Dallas, Texas 75390
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    Dallas, Texas 75234
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    Denison, Texas 75929
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    Houston, Texas 77074
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    Houston, Texas 77030
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    Humble, Texas 77346
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    San Marcos, Texas 78130
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    Waco, Texas 76712
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    Waco, Texas 76710
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    Wichita Falls, Texas 76301
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    Salt Lake City, Utah 84132
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    Burlington, Vermont 05401
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    Norfolk, Virginia 23502
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    Richmond, Virginia 23226
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    Richmond, Virginia 23229
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    Richmond, Virginia 23219
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    Richmond, Virginia 23236
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    Roanoke, Virginia 24014
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    Seattle, Washington 98195
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    Milwaukee, Wisconsin 53226
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