The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/25/2017
Start Date:December 2009
End Date:April 2014

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A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).

This study will test whether darapladib can safely lower the chances of having a
cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g.
medical procedures performed to restore the normal blood flow in patients with
atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome
(also called ACS).

Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo
administered in addition to standard therapy. Following the baseline visit, subjects will be
expected to return for clinic visits at 1 month, 3 months, 6 months and every 6 months until
the end of the study.

Inclusion Criteria:

- Signed written informed consent.

- Men or women at least 18 years old (in Taiwan, at least 20 years old). Women must be
post-menopausal or using a highly effective method for avoidance of pregnancy.

- Hospitalization for acute coronary syndrome (ACS) within 30 days prior to study
entry.

- Clinically stable for 24 hours prior to study entry.

- A planned percutaneous coronary intervention (PCI) should be performed prior to study
entry, whenever possible.

- At least one of the following:

- At least 60 years old.

- Myocardial infarction prior to the qualifying ACS event.

- Diabetes mellitus requiring treatment with medication.

- Diagnosed mild or moderate reduction in kidney function.

- Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months
prior to study entry) OR peripheral artery disease.

Exclusion Criteria:

- ACS symptoms or lab results not believed to be caused by a narrowing or blocked
coronary artery.

- No major coronary artery with a blockage of more than 50% (unless all stenoses are
successfully treated by PCI).

- Planned coronary artery bypass graft (CABG) surgery, or CABG surgery performed after
the qualifying ACS event and prior to study entry.

- Certain types of liver disease.

- Severe reduction in kidney function OR removal of a kidney OR kidney transplant.

- Severe heart failure.

- Blood pressure higher than normal despite lifestyle changes and treatment with
medications.

- Any life-threatening disease with a life expectancy of less than 2 years (other than
heart disease) that may prevent the subject from completing the study.

- Severe asthma that is poorly controlled with medication.

- Pregnancy (Note: A pregnancy test will be performed on all non-sterile women prior to
study entry).

- Previous severe allergic reaction to food, medications, drink, insect stings, etc.

- Drug or alcohol abuse within the past 6 months. Mental/psychological impairment that
may prevent the subject from complying with study procedures or understanding the
goal and potential risks of participating in the study.

- Certain medications that may interfere with the study medication (these will be
identified by the study doctor).

- If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must
have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less
than or equal to 20.0 nmol/min/mL are excluded.

- Previously took darapladib (SB-480848).

- Participation in a study of an investigational medication within the past 30 days.

- Current participation in a study of an investigational device.

- Any other reason the investigator deems the subject should not participate in the
study.
We found this trial at
259
sites
Beverly Hills, California 90211
1979
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from 43215
Beverly Hills, CA
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Albany, New York 12206
514
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Albany, NY
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Albuquerque, New Mexico 87109
1327
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Albuquerque, NM
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Alexandria, Louisiana 71301
797
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Alexandria, LA
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Allentown, Pennsylvania 18102
400
mi
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Allentown, PA
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Amarillo, Texas 79106
1081
mi
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Amarillo, TX
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Anchorage, Alaska 99508
3101
mi
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Anchorage, AK
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Ann Arbor, Michigan 48109
165
mi
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Ann Arbor, MI
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Asheville, North Carolina 28803
304
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Asheville, NC
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Atlanta, Georgia 30341
424
mi
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Atlanta, GA
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Atlantis, Florida 33462
939
mi
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Atlantis, FL
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Augusta, Georgia 30909
452
mi
from 43215
Augusta, GA
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Aurora, Illinois 60504
298
mi
from 43215
Aurora, IL
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Austin, Texas 78705
1064
mi
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Austin, TX
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Aventura, Florida 33180
982
mi
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Aventura, FL
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Avon, Indiana 46123
179
mi
from 43215
Avon, IN
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Ayer, Massachusetts 01432
619
mi
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Ayer, MA
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Bakersfield, California 93309
1982
mi
from 43215
Bakersfield, CA
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Baltimore, Maryland 21201
343
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from 43215
Baltimore, MD
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Bangor, Maine 04401
798
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Bangor, ME
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Bannockburn, Illinois 60015
295
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Bannockburn, IL
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Beaver, Pennsylvania 15009
151
mi
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Beaver, PA
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Bel Air, Maryland 21014
355
mi
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Bel Air, MD
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Bellevue, Washington 98004
2001
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from 43215
Bellevue, WA
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Bellingham, Washington 98225
2016
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Bellingham, WA
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Beloit, Wisconsin 53511
358
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Beloit, WI
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Bethlehem, Pennsylvania 18105
400
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Bethlehem, PA
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Birmingham, Alabama 35249
493
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Birmingham, AL
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Boise, Idaho 83712
1714
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Boise, ID
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Boston, Massachusetts 02115
643
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Boston, MA
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Brandon, Florida 33511
834
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Brandon, FL
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Bridgeport, Connecticut 06606
521
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Bridgeport, CT
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Bronx, New York 10461
486
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Bronx, NY
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Brooklyn, New York 11215
478
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Brooklyn, NY
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Browns Mills, New Jersey 08015
446
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Browns Mills, NJ
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Buffalo, New York 14263
295
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Buffalo, NY
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Burien, Washington 98166
2007
mi
from 43215
Burien, WA
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Burlington, North Carolina 27215
330
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Burlington, NC
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Camp Hill, Pennsylvania 17011
323
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Camp Hill, PA
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Canton, Ohio 44708
101
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Canton, OH
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Capital Federal, Buenos Aires
5386
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Capital Federal,
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Chambersburg, Pennsylvania 17201
283
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Chambersburg, PA
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Charleston, South Carolina 29425
524
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Charleston, SC
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Charlotte, North Carolina 28203
348
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Charlotte, NC
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Chattanooga, Tennessee 37421
359
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Chattanooga, TN
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Chicago, Illinois 60611
274
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Chicago, IL
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Cincinnati, Ohio 45229
96
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Cincinnati, OH
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Clearwater, Florida 33759
828
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Clearwater, FL
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Cleveland, Ohio 44195
129
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Cleveland, OH
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Colorado Springs, Colorado 80910
1161
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Columbia, Maryland 21044
331
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Columbia, Missouri 65201
501
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Columbia, Montana 65201
501
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Columbia, South Carolina 29203
418
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Columbia, Tennessee 38401
371
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Concord, North Carolina 28025
341
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Concord, NC
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Corpus Christi/Texas, Texas 78404
1176
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Cortlandt Manor, New York 10567
488
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Cottonwood, Arizona 86326
1624
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Crestview Hill, Kentucky 41017
103
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Cumming, Georgia 30041
402
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Dallas, Texas 75230
905
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Dallas, TX
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Dayton, Ohio 45420
60
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Dayton, OH
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Daytona Beach, Florida 32117
749
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Dearborn, Michigan 48126
164
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Detroit, Michigan 48202
165
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Doylestown, Pennsylvania 18901
417
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Duluth, Minnesota 55805
655
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Elizabeth, New Jersey 07201
466
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Elizabeth, NJ
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Elmer, New Jersey 08318
417
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Elyria, Ohio 44035
108
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Elyria, OH
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Erie, Pennsylvania 16507
214
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Everett, Washington 98201
2000
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Fairfield, Ohio 45014
92
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Fairview Park, Ohio 44126
99
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Fall River, Massachusetts 02720
633
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Fleming Island, Florida 32003
685
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Fleming Island, FL
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Flint, Michigan 48504
216
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Flint, MI
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Fort Lauderdale, Florida 33308
966
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Fort Smith, Arkansas 72903
697
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Fort Wayne, Indiana 46825
136
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Fort Worth, Texas 76104
937
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Fresno, California 93720
1986
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Fresno, CA
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Gainesville, Florida 32610
713
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Galveston, Texas 77555
992
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Gastonia, North Carolina 28054
341
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Glendale, Arizona 85304
1663
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Glendale, California 91204
1970
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Golden, Colorado 80401
1174
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Golden, CO
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Grand Forks, North Dakota 58201
885
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Grand Forks, ND
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Grand Island, Nebraska 68803
809
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Grand Island, NE
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Great Falls, Montana 59405
1493
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Greeley, Colorado 80631
1142
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Greeley, CO
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Green Bay, Wisconsin 54301
403
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Green Bay, WI
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Greensboro, North Carolina 27403
320
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Greensboro, NC
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Greenville, South Carolina 29615
353
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Guilford, Connecticut 06437
549
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Guilford, CT
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Gulf Breeze, Florida 32561
703
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Gulf Breeze, FL
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Haddon Heights, New Jersey 08035
421
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Haddon Heights, NJ
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Hammond, Indiana 46320
259
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Hammond, IN
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Harker Heights, Texas 76548
1024
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Harker Heights, TX
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