Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study



Status:Completed
Conditions:Colitis, Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:October 2006
End Date:December 2008

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A Multicenter, Open-label Trials to Evaluate the Long-term Safety and Tolerability of a New Balsalazide Disodium Tablet Formulation in Patients With Ulcerative Colitis

The objective of the study is to evaluate the long-term safety and tolerability of treatment
with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or
who have mildly to moderately active UC.

The objective of the study is to evaluate the long-term safety and tolerability of treatment
with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or
who have mildly to moderately active UC.

Inclusion Criteria:

- Subject has a documented history of UC and is either in remission or currently
presents with mildly to moderately active UC symptoms as determined by the
investigator upon subject interview of UC symptoms, (e.g., urgency, bowel frequency,
and rectal bleeding). Additionally, the diagnosis of UC must be confirmed by past
flexible sigmoidoscopy/colonoscopy which may include colonic mucosal pathological
findings on biopsy consistent with UC.

- Subject is capable and willing to comply with all study procedures.

Exclusion Criteria:

- Subject has a history of allergy or intolerance to aspirin, mesalamine or other
salicylates.

- Subject has participated in an investigational drug or device study, other than a
previous balsalazide disodium tablet trial (i.e., BZUC3002 or BZUC3003), within 30
days of entering the current study.

- Subject discontinued from a previous balsalazide disodium tablet study due to study
drug-related AE(s), including UC flare or associated symptoms that were perceived by
the subject/investigator as being caused by study drug.

- Subject has had any prior bowel surgery, except appendectomy and cholecystectomy.

- Subject has unstable cardiovascular, coagulopathy, or pulmonary disease.

- Regular use of nonsteroidal anti-inflammatory drugs (NSAIDS) except cardioprotective
ASA (i.e., less than or equal to 162 mg ASA per day).

- Subject has a history of human immunodeficiency virus (HIV) or hepatitis (B and C).
Subjects with a history of hepatitis B and C will be eligible provided the screening
LFTs are within normal limits.
We found this trial at
95
sites
Lone Tree, Colorado
817
mi
from 91732
Lone Tree, CO
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5458 Town Center Rd # 19
Boca Raton, Florida 33486
2309
mi
from 91732
Boca Raton, FL
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
2340
mi
from 91732
Chesapeake, VA
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610 3rd St # 206
Macon, Georgia 31201
1974
mi
from 91732
Macon, GA
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4224 North Tampania Avenue
Tampa, Florida 33607
2134
mi
from 91732
Tampa, FL
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701 West Morse Boulevard
Winter Park, Florida 32789
2184
mi
from 91732
Winter Park, FL
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1085 North Harbor Boulevard
Anaheim, California 92801
16
mi
from 91732
Anaheim, CA
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Anderson, Indiana 46011
1819
mi
from 91732
Anderson, IN
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Annapolis, Maryland 21401
2309
mi
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Annapolis, MD
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Atlanta, Georgia 30342
1918
mi
from 91732
Atlanta, GA
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Austin, Texas 78705
1211
mi
from 91732
Austin, TX
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2411 West Belvedere Avenue
Baltimore, Maryland 21215
2298
mi
from 91732
Baltimore, MD
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4600 Wilkens Avenue
Baltimore, Maryland 21229
2297
mi
from 91732
Baltimore, MD
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9103 Jefferson Highway
Baton Rouge, Louisiana 70809
1588
mi
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Baton Rouge, LA
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1785
mi
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Birmingham, AL
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Braintree, Massachusetts 02184
2581
mi
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Braintree, MA
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Bristol, Connecticut 06010
2484
mi
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Bristol, CT
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2726 Fulton Drive Northwest
Canton, Ohio 44718
2045
mi
from 91732
Canton, OH
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1962 Charlie Hall Boulevard
Charleston, South Carolina 29414
2178
mi
from 91732
Charleston, SC
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Charlotte, North Carolina 28207
2102
mi
from 91732
Charlotte, NC
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Chattanooga, Tennessee 37421
1862
mi
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Chattanooga, TN
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Chesterfield, Michigan 48098
1963
mi
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Chesterfield, MI
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Chevy Chase, Maryland 20815
2277
mi
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Chevy Chase, MD
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1879
mi
from 91732
Cincinnati, OH
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317 Howell Avenue
Cincinnati, Ohio 45220
1879
mi
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Cincinnati, OH
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Clive, Iowa 50325
1414
mi
from 91732
Clive, IA
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1899
mi
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Dayton, OH
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Decatur, Georgia 30033
1924
mi
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Decatur, GA
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240 Williamson Street
Elizabeth, New Jersey 07202
2422
mi
from 91732
Elizabeth, NJ
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221 13th Avenue Place Northwest
Elkin, North Carolina 28621
2068
mi
from 91732
Elkin, NC
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Encinitas, California 92024
82
mi
from 91732
Encinitas, CA
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1100 North Woolsey Avenue
Fayetteville, Arkansas 72703
1352
mi
from 91732
Fayetteville, AR
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Garden Grove, California 92840
20
mi
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Garden Grove, CA
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1945 Boston Street Southeast
Grand Rapids, Michigan 49506
1841
mi
from 91732
Grand Rapids, MI
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1000 Northern Boulevard
Great Neck, New York 11021
2448
mi
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Great Neck, NY
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Greensboro, North Carolina 27406
2152
mi
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Greensboro, NC
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Greenville, North Carolina 27834
2290
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Greenville, NC
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Hagerstown, Maryland 21740
2240
mi
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Hagerstown, MD
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
2296
mi
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Hershey, PA
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590 East 25th Street
Hialeah, Florida 33010
2315
mi
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Hialeah, FL
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Hollywood, Florida 33021
2315
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Hollywood, FL
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3800 Johnson Street
Hollywood, Florida 33021
2316
mi
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Hollywood, FL
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Hollywood, Florida 33021
2315
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Hollywood, FL
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24035 Three Notch Road
Hollywood, Maryland 20636
2310
mi
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Hollywood, MD
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1357
mi
from 91732
Houston, TX
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17070 Red Oak Drive
Houston, Texas 77090
1348
mi
from 91732
Houston, TX
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1357
mi
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Houston, TX
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1901 North MacArthur Boulevard
Irving, Texas 75601
1214
mi
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Irving, TX
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Jackson, Mississippi 39202
1609
mi
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Jackson, MS
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Jacksonville, North Carolina 28546
2298
mi
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Jacksonville, NC
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Lakewood, Colorado 80214
812
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Lakewood, CO
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560 West Main Street
Lewisville, Texas 75057
1209
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Lewisville, TX
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1001 Southpark Drive
Littleton, Colorado 80120
812
mi
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Littleton, CO
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8110 Airport Boulevard
Los Angeles, California 90045
22
mi
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Los Angeles, CA
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7801 York Road
Lutherville, Maryland 21093
2301
mi
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Lutherville, MD
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8000 Wolf River Boulevard
Memphis, Tennessee 38138
1601
mi
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Memphis, TN
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Metairie, Louisiana 70006
1648
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Metairie, LA
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1485
mi
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Mexico, MO
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8370 West Flagler Street
Miami, Florida 33144
2314
mi
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Miami, FL
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Milwaukee, Wisconsin 53215
1726
mi
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Milwaukee, WI
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Milwaukee, Wisconsin 53215
1726
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Milwaukee, WI
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2010 Church Street
Nashville, Tennessee 37203
1762
mi
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Nashville, TN
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Nashville, Tennessee 37205
1759
mi
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Nashville, TN
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New Smyrna Beach, Florida 32168
2197
mi
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New Smyrna Beach, FL
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2434
mi
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New York, NY
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12 East 86th Street
New York, New York 10128
2434
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New York, NY
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Newnan, Georgia 30263
1899
mi
from 91732
Newnan, GA
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Norfolk, Virginia 23502
2341
mi
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Norfolk, VA
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16853 Northeast 2nd Avenue
North Miami Beach, Florida 33162
2317
mi
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North Miami Beach, FL
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836 West Wellington Avenue
Oak Forest, Illinois 60452
1729
mi
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Oak Forest, IL
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3200 Sunset Avenue
Ocean City, New Jersey 07712
2433
mi
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Ocean City, NJ
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Ogden, Utah 84405
590
mi
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Ogden, UT
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Oklahoma City, Oklahoma 73112
1161
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Oklahoma City, OK
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Orange, California 92868
21
mi
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Orange, CA
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
2375
mi
from 91732
Philadelphia, PA
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9701 Southwest Barnes Road
Portland, Oregon 97225
829
mi
from 91732
Portland, OR
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
2214
mi
from 91732
Raleigh, NC
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1201 Broad Rock Boulevard
Richmond, Virginia 23249
2267
mi
from 91732
Richmond, VA
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Saint Louis, Missouri 63128
1562
mi
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Saint Louis, MO
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San Antonio, Texas 78229
1182
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San Antonio, TX
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300 Fir Street
San Diego, California 92101
105
mi
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San Diego, CA
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Sayre, Pennsylvania 18840
2299
mi
from 91732
Sayre, PA
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Seattle, Washington 98133
970
mi
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Seattle, WA
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Stony Brook, New York 11794
2503
mi
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Stony Brook, NY
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1112 6th Avenue
Tacoma, Washington 98405
939
mi
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Tacoma, WA
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1265 West Guadalupe Road
Tempe, Arizona 85282
356
mi
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Tempe, AZ
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1280
mi
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Topeka, KS
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Tulsa, Oklahoma 74135
1253
mi
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Tulsa, OK
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Urbana, Illinois 58150
1686
mi
from 91732
Urbana, IL
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602 West Sherman Avenue
Vineland, New Jersey 08360
2384
mi
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Vineland, NJ
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Warren, Ohio 44484
2076
mi
from 91732
Warren, OH
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Wilmington, North Carolina 28401
2275
mi
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Wilmington, NC
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Wilmington, North Carolina 28403
2275
mi
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Wilmington, NC
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Winston-salem, North Carolina 27103
2122
mi
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Winston-salem, NC
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Zephyrhills, Florida 33542
2145
mi
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Zephyrhills, FL
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