Phase
Condition
Asthma
Treatment
Placebo MDI HFA
BDA MDI HFO 160/180 μg
BDA MDI HFA 160/180 μg
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be ≥ 18 years of age at the time of signing the ICF.
Participants who have physician diagnosed asthma as defined by GINA for at least 12months prior to Visit 1.
Eligible participants are on either a) no daily inhaled maintenance therapy or b)daily inhaled maintenance therapy with low-dose ICS or low-dose ICS-LABA.Participants who are on low-dose ICS maintenance therapy are required to be stableon therapy for a minimum of 3 months prior to Visit 1; participants using low-doseICSLABA maintenance regimens are required to be stable on therapy for a minimum of 6months prior to Visit 1.
Participants with a pre-bronchodilator FEV1 of ≥ 60% and < 90% predicted normal atVisit 1 or Visit 1a.
Participants with a pre-dose FEV1 of ≥ 60% and < 90% predicted normal at Visit 2that is within ± 20% of their Visit 1 pre-bronchodilator FEV1.
Participants who demonstrate bronchodilator responsiveness defined as a > 12% and > 200 mL increase in FEV1 relative to baseline following administration of studyprovided SABA at Visit 1 or Visit 1a.
Participants able to demonstrate acceptable spirometry performance as defined by theacceptability and repeatability criteria in the ATS/ERS Standardization ofSpirometry 2019 update
Participants who are willing and, in the opinion of the investigator, able to adjustcurrent asthma therapy, as required by the protocol.
Participants with a body mass index < 40 kg/m2.
Females must not be of childbearing potential or, if of childbearing potential,using a form of birth control
Exclusion
Exclusion Criteria:
Confirmed or suspected diagnosis of COPD or clinically significant non-asthmaairway/lung disease.
Systemic corticosteroid use (eg, prednisone for 3 or more days or a singledepo-injectable dose of corticosteroids) for any respiratory, immune, orallergy-attributed disease within 6 months prior to Visit 1.
An upper respiratory infection requiring antibiotic treatment that is not resolvedwithin 7 days prior to Visit 1.
A lower respiratory infection in the 4 weeks prior to Visit 1.
Life-threatening asthma defined as any history of significant asthma episode(s)requiring admission to an intensive care unit, positive pressure ventilationassociated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-relatedsyncopal episode(s) within 5 years of Visit 1.
Hospitalization due to asthma within 12 months or systemic corticosteroid usage (eg,prednisone for 3 or more days or a single depo-injectable dose of corticosteroids)for asthma within 6 months prior to Visit 1.
A severe asthma exacerbation during the run-in period
An ePRO device alert during the run-in period with investigator-confirmed worseningasthma symptoms
Historical or current evidence of a clinically significant disease including, butnot limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm,clinically significant cardiac arrhythmia, coronary heart disease), hepatic, renal,hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus,uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), orgastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal refluxdisease) disorders. Significant is defined as any disease that, in the opinion ofthe investigator, would put the safety of the participant at risk through studyparticipation or that could affect the efficacy or safety analyses if thedisease/condition exacerbated during the study.
Unresectable cancer that has not been in complete remission for at least 5 yearsprior to Visit 1
Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit
- Known history of drug or alcohol abuse within 12 months of Visit 1 or known abuse atany time during the study.
Study Design
Study Description
Connect with a study center
Research Site
Anhui, 230061
ChinaSite Not Available
Research Site
Baotou, 014010
ChinaSite Not Available
Research Site
Baotou 2038432, 014010
ChinaSite Not Available
Research Site
Changsha, 410015
ChinaSite Not Available
Research Site
Changsha 1815577, 410015
ChinaSite Not Available
Research Site
Chengdu, 610072
ChinaSite Not Available
Research Site
Chengdu 1815286, 610072
ChinaSite Not Available
Research Site
Chizhou, 247099
ChinaSite Not Available
Research Site
Chizhou 1814934, 247099
ChinaSite Not Available
Research Site
Chongqing, 401320
ChinaSite Not Available
Research Site
Chongqing 1814906, 401320
ChinaSite Not Available
Research Site
Guangzhou, 510163
ChinaSite Not Available
Research Site
Guangzhou 1809858, 510150
ChinaSite Not Available
Research Site
Haikou, 570208
ChinaSite Not Available
Research Site
Haikou 1809078, 570208
ChinaSite Not Available
Research Site
Hangzhou, 310005
ChinaSite Not Available
Research Site
Hangzhou 1808926, 310005
ChinaSite Not Available
Research Site
Hefei, 230061
ChinaSite Not Available
Research Site
Hefei 1808722, 230061
ChinaSite Not Available
Research Site
Hohhot, 010017
ChinaSite Not Available
Research Site
Hohhot 2036892, 010017
ChinaSite Not Available
Research Site
Huizhou, 516001
ChinaSite Not Available
Research Site
Huizhou 1806776, 516001
ChinaSite Not Available
Research Site
Jinan, 250001
ChinaSite Not Available
Research Site
Jinan 1805753, 250001
ChinaSite Not Available
Research Site
Jinhua,
ChinaSite Not Available
Research Site
Jinhua 1805528,
ChinaSite Not Available
Research Site
Lanzhou, 730000
ChinaSite Not Available
Research Site
Lanzhou 1804430, 730000
ChinaSite Not Available
Research Site
Linhai, 317000
ChinaSite Not Available
Research Site
Linhai 9906214, 317000
ChinaSite Not Available
Research Site
Nanchang, 330006
ChinaSite Not Available
Research Site
Nanchang 1800163, 330006
ChinaSite Not Available
Research Site
Pingxiang, 337055
ChinaSite Not Available
Research Site
Pingxiang 1798654, 337055
ChinaSite Not Available
Research Site
Qingdao, 266011
ChinaSite Not Available
Research Site
Qingdao 1797929, 266011
ChinaSite Not Available
Research Site
Shanghai, 200080
ChinaSite Not Available
Research Site
Shanghai 1796236, 310000
ChinaSite Not Available
Research Site
Shenyang, 110004
ChinaSite Not Available
Research Site
Shenyang 2034937, 110004
ChinaSite Not Available
Research Site
Shenzhen, 518020
ChinaSite Not Available
Research Site
Shenzhen 1795565, 518020
ChinaSite Not Available
Research Site
Shijiazhuang, 50051
ChinaSite Not Available
Research Site
Shijiazhuang 1795270, 50051
ChinaSite Not Available
Research Site
Taiyuan, 030032
ChinaSite Not Available
Research Site
Taiyuan 1793511, 030032
ChinaSite Not Available
Research Site
Wenzhou, 325027
ChinaSite Not Available
Research Site
Wenzhou 1791388, 325027
ChinaSite Not Available
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Wuhan, 430030
ChinaSite Not Available
Research Site
Wuhan 1791247, 430030
ChinaSite Not Available
Research Site
Xi'an, 710006
ChinaSite Not Available
Research Site
Xi'an 1790630, 710006
ChinaSite Not Available
Research Site
Xuzhou, 221000
ChinaSite Not Available
Research Site
Xuzhou 10630003, 221009
ChinaSite Not Available
Research Site
Yangzhou, 225003
ChinaSite Not Available
Research Site
Yangzhou 1787227, 225003
ChinaSite Not Available
Research Site
Yinchuan, 750001
ChinaSite Not Available
Research Site
Yinchuan 1786657, 750001
ChinaSite Not Available
Research Site
Zhejiang, 311800
ChinaSite Not Available
Research Site
Zhengzhou, 450003
ChinaSite Not Available
Research Site
Zhengzhou 1784658, 450003
ChinaSite Not Available
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Zhuji, 311899
ChinaSite Not Available
Research Site
Zhuji 1783940, 311899
ChinaSite Not Available
Research Site
Alor Setar, 05400
MalaysiaSite Not Available
Research Site
Alor Star 1736309, 05400
MalaysiaSite Not Available
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Ampang, 68000
MalaysiaSite Not Available
Research Site
Ampang 1735168, 68000
MalaysiaSite Not Available
Research Site
Cheras, 56000
MalaysiaSite Not Available
Research Site
Cheras 1777077, 56000
MalaysiaSite Not Available
Research Site
Petaling Jaya, 47500
MalaysiaSite Not Available
Research Site
Petaling Jaya 1735158, 47500
MalaysiaSite Not Available
Research Site
Rawang, 48050
MalaysiaSite Not Available
Research Site
Rawang 1735150, 48050
MalaysiaSite Not Available
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Sandakan, 90000
MalaysiaSite Not Available
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Sandakan 1734052, 90000
MalaysiaSite Not Available
Research Site
Chihuahua, 31200
MexicoSite Not Available
Research Site
Chihuahua City 4014338, 31200
MexicoSite Not Available
Research Site
Cuernavaca, 62290
MexicoSite Not Available
Research Site
Cuernavaca 3529947, 62290
MexicoSite Not Available
Research Site
Culiacan, 80100
MexicoSite Not Available
Research Site
Culiacán 4012176, 80100
MexicoSite Not Available
Research Site
Durango, 34000
MexicoSite Not Available
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Durango 4011743, 34000
MexicoSite Not Available
Research Site
Guadalajara, 44130
MexicoSite Not Available
Research Site
Guadalajara 4005539, 44200
MexicoSite Not Available
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Mazatlán, 82000
MexicoSite Not Available
Research Site
Mazatlán 3996322, 82000
MexicoSite Not Available
Research Site
Mexico City, 3103
MexicoSite Not Available
Research Site
Mexico City 3530597, 3103
MexicoSite Not Available
Research Site
Monterrey, 64060
MexicoSite Not Available
Research Site
Monterrey 3995465, 64060
MexicoSite Not Available
Research Site
Mérida, 97070
MexicoSite Not Available
Research Site
Mérida 3523349, 97070
MexicoSite Not Available
Research Site
San Juan del Rio, 76800
MexicoSite Not Available
Research Site
San Juan del Río 3518692, 76800
MexicoSite Not Available
Research Site
Tijuana, 22010
MexicoSite Not Available
Research Site
Tijuana 3981609, 22010
MexicoSite Not Available
Research Site
Veracruz, 91900
MexicoSite Not Available
Research Site
Veracruz 3514783, 91900
MexicoSite Not Available
Research Site
Zapopan, 45138
MexicoSite Not Available
Research Site
Zapopan 3979770, 45138
MexicoSite Not Available
Research Site
Bangkoknoi, 10700
ThailandSite Not Available
Research Site
Khon Kaen, 40002
ThailandSite Not Available
Research Site
Khon Kaen 1609776, 40002
ThailandSite Not Available
Research Site
Mueang, 50200
ThailandSite Not Available
Research Site
Ratchathewi, 10400
ThailandSite Not Available
Research Site
Ratchathewi 7026885, 10400
ThailandSite Not Available
Research Site
Abu Dhabi,
United Arab EmiratesSite Not Available
Research Site
Abu Dhabi 292968,
United Arab EmiratesSite Not Available
Research Site
Ashton-under-Lyne, OL6 6EW
United KingdomSite Not Available
Research Site
Ashton-under-Lyne 2656915, OL6 6EW
United KingdomSite Not Available
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Glasgow, G20 7BE
United KingdomSite Not Available
Research Site
Glasgow 2648579, G20 7BE
United KingdomSite Not Available
Research Site
Newcastle, NE6 1SG
United KingdomSite Not Available
Research Site
Newcastle upon Tyne 2641673, NE6 1SG
United KingdomSite Not Available
Research Site
Newcastle-Upon-Tyne, NE6 1SG
United KingdomSite Not Available
Research Site
Mobile, Alabama 36608
United StatesSite Not Available
Research Site
Sheffield, Alabama 35660
United StatesSite Not Available
Research Site
Mobile 4076598, Alabama 4829764 36608
United StatesSite Not Available
Research Site
Sheffield 4089536, Alabama 4829764 35660
United StatesSite Not Available
Research Site
Phoenix, Arizona 85018
United StatesSite Not Available
Research Site
Phoenix 5308655, Arizona 5551752 85018
United StatesSite Not Available
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Little Rock, Arkansas 72205
United StatesSite Not Available
Research Site
Little Rock 4119403, Arkansas 4099753 72205
United StatesSite Not Available
Research Site
Banning, California 92220
United StatesSite Not Available
Research Site
Encinitas, California 92024
United StatesSite Not Available
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Fullerton, California 92835
United StatesSite Not Available
Research Site
Gardena, California 90247
United StatesSite Not Available
Research Site
Huntington Beach, California 92647
United StatesSite Not Available
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La Mesa, California 91942
United StatesSite Not Available
Research Site
Los Angeles, California 90048
United StatesSite Not Available
Research Site
Panorama City, California 91402
United StatesSite Not Available
Research Site
Sacramento, California 95821
United StatesSite Not Available
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San Bernardino, California 92408
United StatesSite Not Available
Research Site
San Diego, California 92123
United StatesSite Not Available
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San Jose, California 95117
United StatesSite Not Available
Research Site
Santa Ana, California 92704
United StatesSite Not Available
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Stockton, California 95207
United StatesSite Not Available
Research Site
Van Nuys, California 91405
United StatesSite Not Available
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Westminster, California 92683
United StatesSite Not Available
Research Site
Encinitas 5346646, California 5332921 92024
United StatesSite Not Available
Research Site
Fullerton 5351247, California 5332921 92835
United StatesSite Not Available
Research Site
Gardena 5351549, California 5332921 90247
United StatesSite Not Available
Research Site
Huntington Beach 5358705, California 5332921 92647
United StatesSite Not Available
Research Site
La Mesa 5363990, California 5332921 91942
United StatesSite Not Available
Research Site
Los Angeles 5368361, California 5332921 90048
United StatesSite Not Available
Research Site
Sacramento 5389489, California 5332921 95821
United StatesSite Not Available
Research Site
San Bernardino 5391710, California 5332921 92408
United StatesSite Not Available
Research Site
San Diego 5391811, California 5332921 92123
United StatesSite Not Available
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San Jose 5392171, California 5332921 95117
United StatesSite Not Available
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Santa Ana 5392900, California 5332921 92704
United StatesSite Not Available
Research Site
Stockton 5399020, California 5332921 95207
United StatesSite Not Available
Research Site
Van Nuys 5405693, California 5332921 91405
United StatesSite Not Available
Research Site
Westminster 5408406, California 5332921 92683
United StatesSite Not Available
Research Site
Englewood, Colorado 80110
United StatesSite Not Available
Research Site
Wheat Ridge, Colorado 80033
United StatesSite Not Available
Research Site
Englewood 5421250, Colorado 5417618 80110
United StatesSite Not Available
Research Site
Wheat Ridge 5443948, Colorado 5417618 80033
United StatesSite Not Available
Research Site
Washington, District of Columbia 20016
United StatesSite Not Available
Research Site
Washington D.C. 4140963, District of Columbia 4138106 20016
United StatesSite Not Available
Research Site
Boynton Beach, Florida 33435
United StatesSite Not Available
Research Site
Miami, Florida 33175
United StatesSite Not Available
Research Site
Tallahassee, Florida 32308
United StatesSite Not Available
Research Site
Tampa, Florida 33607
United StatesSite Not Available
Research Site
Boynton Beach 4148677, Florida 4155751 33435
United StatesSite Not Available
Research Site
Miami 4164138, Florida 4155751 33175
United StatesSite Not Available
Research Site
Tallahassee 4174715, Florida 4155751 32308
United StatesSite Not Available
Research Site
Tampa 4174757, Florida 4155751 33607
United StatesSite Not Available
Research Site
Atlanta, Georgia 30328
United StatesSite Not Available
Research Site
Rincon, Georgia 31326
United StatesSite Not Available
Research Site
Savannah, Georgia 31406
United StatesSite Not Available
Research Site
Atlanta 4180439, Georgia 4197000 30328
United StatesSite Not Available
Research Site
Rincon 4218882, Georgia 4197000 31326
United StatesSite Not Available
Research Site
Savannah 4221552, Georgia 4197000 31406
United StatesSite Not Available
Research Site
Boise, Idaho 83706
United StatesSite Not Available
Research Site
Meridian, Idaho 83646
United StatesSite Not Available
Research Site
Boise 5586437, Idaho 5596512 83706
United StatesSite Not Available
Research Site
Meridian 5600685, Idaho 5596512 83646
United StatesSite Not Available
Research Site
River Forest, Illinois 60305
United StatesSite Not Available
Research Site
River Forest 4907637, Illinois 4896861 60305
United StatesSite Not Available
Research Site
Evansville, Indiana 47715
United StatesSite Not Available
Research Site
Valparaiso, Indiana 46383
United StatesSite Not Available
Research Site
Evansville 4257227, Indiana 4921868 47715
United StatesSite Not Available
Research Site
Valparaiso 4927537, Indiana 4921868 46383
United StatesSite Not Available
Research Site
Sioux City, Iowa 51106
United StatesSite Not Available
Research Site
Sioux City 4876523, Iowa 4862182 51106
United StatesSite Not Available
Research Site
Lexington, Kentucky 40509
United StatesSite Not Available
Research Site
Louisville, Kentucky 40217
United StatesSite Not Available
Research Site
Louisville 4299276, Kentucky 6254925 40217
United StatesSite Not Available
Research Site
Lafayette, Louisiana 70508
United StatesSite Not Available
Research Site
Metairie, Louisiana 70006
United StatesSite Not Available
Research Site
New Orleans, Louisiana 70119
United StatesSite Not Available
Research Site
Lafayette 4330145, Louisiana 4331987 70508
United StatesSite Not Available
Research Site
New Orleans 4335045, Louisiana 4331987 70119
United StatesSite Not Available
Research Site
White Marsh, Maryland 21162
United StatesSite Not Available
Research Site
White Marsh 4373426, Maryland 4361885 21162
United StatesSite Not Available
Research Site
Flint, Michigan 48504
United StatesSite Not Available
Research Site
Flint 4992982, Michigan 5001836 48504
United StatesSite Not Available
Research Site
Columbia, Missouri 65203
United StatesSite Not Available
Research Site
Saint Louis, Missouri 63141
United StatesSite Not Available
Research Site
Columbia 4381982, Missouri 4398678 65203
United StatesSite Not Available
Research Site
St Louis 4407066, Missouri 4398678 63141
United StatesSite Not Available
Research Site
Bellevue, Nebraska 68123
United StatesSite Not Available
Research Site
Omaha, Nebraska 68134
United StatesSite Not Available
Research Site
Omaha 5074472, Nebraska 5073708 68134
United StatesSite Not Available
Research Site
Middletown, New York 10940
United StatesSite Not Available
Research Site
Monticello, New York 12701
United StatesSite Not Available
Research Site
New York, New York 10036
United StatesSite Not Available
Research Site
Watertown, New York 13601
United StatesSite Not Available
Research Site
Monticello 5127359, New York 5128638 12701
United StatesSite Not Available
Research Site
New York 5128581, New York 5128638 10036
United StatesSite Not Available
Research Site
Watertown 5143396, New York 5128638 13601
United StatesSite Not Available
Research Site
Charlotte, North Carolina 28273
United StatesSite Not Available
Research Site
Raleigh, North Carolina 27607
United StatesSite Not Available
Research Site
Charlotte 4460243, North Carolina 4482348 28273
United StatesSite Not Available
Research Site
Raleigh 4487042, North Carolina 4482348 27607
United StatesSite Not Available
Research Site
Cincinnati, Ohio 45236
United StatesSite Not Available
Research Site
Cincinnati 4508722, Ohio 5165418 45236
United StatesSite Not Available
Research Site
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
Research Site
Tulsa, Oklahoma 74136
United StatesSite Not Available
Research Site
Oklahoma City 4544349, Oklahoma 4544379 73120
United StatesSite Not Available
Research Site
Tulsa 4553433, Oklahoma 4544379 74136
United StatesSite Not Available
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Medford, Oregon 97504
United StatesSite Not Available
Research Site
Portland, Oregon 97202
United StatesSite Not Available
Research Site
Medford 5740099, Oregon 5744337 97504
United StatesSite Not Available
Research Site
Portland 5746545, Oregon 5744337 97202
United StatesSite Not Available
Research Site
DuBois, Pennsylvania 15801
United StatesSite Not Available
Research Site
Pottstown, Pennsylvania 19464
United StatesSite Not Available
Research Site
Scottdale, Pennsylvania 15683
United StatesSite Not Available
Research Site
Pottstown 5207069, Pennsylvania 6254927 19464
United StatesSite Not Available
Research Site
Scottdale 5211279, Pennsylvania 6254927 15683
United StatesSite Not Available
Research Site
Charleston, South Carolina 29414
United StatesSite Not Available
Research Site
Greenville, South Carolina 29615
United StatesSite Not Available
Research Site
North Charleston, South Carolina 29420
United StatesSite Not Available
Research Site
Spartanburg, South Carolina 29303
United StatesSite Not Available
Research Site
Charleston 4574324, South Carolina 4597040 29414
United StatesSite Not Available
Research Site
Greenville 4580543, South Carolina 4597040 29615
United StatesSite Not Available
Research Site
North Charleston 4589387, South Carolina 4597040 29420
United StatesSite Not Available
Research Site
Spartanburg 4597200, South Carolina 4597040 29303
United StatesSite Not Available
Research Site
Boerne, Texas 78006
United StatesSite Not Available
Research Site
Dallas, Texas 75231
United StatesSite Not Available
Research Site
DeSoto, Texas 75115
United StatesSite Not Available
Research Site
El Paso, Texas 79924
United StatesSite Not Available
Research Site
Kingwood, Texas 77339
United StatesSite Not Available
Research Site
McKinney, Texas 75069
United StatesSite Not Available
Research Site
Pearland, Texas 77584
United StatesSite Not Available
Research Site
San Antonio, Texas 78258
United StatesSite Not Available
Research Site
Victoria, Texas 77901
United StatesSite Not Available
Research Site
Boerne 4675373, Texas 4736286 78006
United StatesSite Not Available
Research Site
Dallas 4684888, Texas 4736286 75231
United StatesSite Not Available
Research Site
DeSoto 4685524, Texas 4736286 75115
United StatesSite Not Available
Research Site
El Paso 5520993, Texas 4736286 79924
United StatesSite Not Available
Research Site
Kingwood 7534469, Texas 4736286 77339
United StatesSite Not Available
Research Site
McKinney 4710178, Texas 4736286 75069
United StatesSite Not Available
Research Site
Pearland 4718097, Texas 4736286 77584
United StatesSite Not Available
Research Site
San Antonio 4726206, Texas 4736286 78258
United StatesSite Not Available
Research Site
Victoria 4739157, Texas 4736286 77901
United StatesSite Not Available
Research Site
West Jordan, Utah 84088
United StatesSite Not Available
Research Site
West Jordan 5784549, Utah 5549030 84088
United StatesSite Not Available
Research Site
Burke, Virginia 22015
United StatesSite Not Available
Research Site
Portsmouth, Virginia 23703
United StatesSite Not Available
Research Site
Burke 4749950, Virginia 6254928 22015
United StatesSite Not Available
Research Site
Portsmouth 4779999, Virginia 6254928 23703
United StatesSite Not Available
Research Site
Spokane, Washington 99218
United StatesSite Not Available
Research Site
Spokane 5811696, Washington 5815135 99218
United StatesSite Not Available
Research Site
Morgantown, West Virginia 26505
United StatesSite Not Available
Research Site
Morgantown 4815352, West Virginia 4826850 26505
United StatesSite Not Available
Research Site
Milwaukee, Wisconsin 53228
United StatesSite Not Available
Research Site
Milwaukee 5263045, Wisconsin 5279468 53228
United StatesSite Not Available
Research Site
Can Tho, 900000
VietnamSite Not Available
Research Site
Can Tho 1586203, 900000
VietnamSite Not Available
Research Site
Hai Phong, 180000
VietnamSite Not Available
Research Site
Haiphong 1581298, 180000
VietnamSite Not Available
Research Site
Hanoi, 100000
VietnamSite Not Available
Research Site
Hanoi 1581130, 100000
VietnamSite Not Available
Research Site
Ho Chi Minh, 700000
VietnamSite Not Available
Research Site
Ho Chi Minh City, 700000
VietnamSite Not Available
Research Site
Ho Chi Minh City 1566083, 700000
VietnamSite Not Available

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