Bexagliflozin Efficacy and Safety Trial

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Bexagliflozin

Registration Number: NCT02558296

Lead Sponsor: Theracos

Brief Summary: The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased risk of cardiovascular adverse events.

The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.

Detailed Description: Approximately 130 investigative sites globally are planned to participate in this study.

An estimated 1650 subjects with inadequately controlled T2DM and an elevated risk of cardiovascular adverse events will be randomized to bexagliflozin tablets, 20 mg, or placebo in a ratio of 2:1 in addition to the background anti-diabetic medications.

The study is an event-driven trial. The treatment period will end when the last randomized subject has completed at least 52 weeks of treatment and a total of at least 134 subjects have experienced a cardiac event.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1700

Inclusion Criteria

Subjects with a diagnosis of T2DM
Subjects who have had a stable treatment regimen for T2DM for the past 3 months
Subjects who present with at least one of the following 3 histories:

Group 1: A history of atherosclerotic vascular disease Group 2: A history of heart failure Group 3: Age ≥ 55 years with diabetes for ≥ 10 years, uncontrolled hypertension, currently smoking, reduced kidney function, or cholesterol problems

Exclusion Criteria

Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
History of genitourinary tract infections
Evidence of abnormal liver function
History of MI, stroke or hospitalization for heart failure in the past 3 months
Prior kidney transplant or evidence of kidney problems
Prior or planned pace maker implantation
Pregnant or nursing

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo tablets	Placebo	Each subject will receive placebo (inactive tablet) once daily for the duration of the study.
Bexagliflozin tablets, 20 mg	Bexagliflozin	Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline to Week 24	24 weeks	The primary efficacy objective of this trial is to evaluate the placebo-adjusted change in HbA1c from baseline after 24 weeks of treatment with 20 mg bexagliflozin tablets in type 2 diabetic subjects with increased risk of cardiovascular adverse events.

Secondary Outcome Measures

Name	Time	Method
Change in Body Weight From Baseline to Week 48	48 weeks	To evaluate the effect of 20 mg bexagliflozin on the change in body weight from baseline to week 48 in randomized subjects with a BMI ≥ 25 kg/m2 compared to placebo
Change in Systolic Blood Pressure From Baseline to Week 24 in Subjects Hypertensive at Baseline	24 weeks	To evaluate the effect of 20 mg bexagliflozin on the change in systolic blood pressure (SBP) from baseline to week 24 in subjects with baseline systolic blood pressure ≥ 140 mmHg compared to placebo
Change From Baseline in HbA1c at Week 24 for Subjects Who Have Been Prescribed Insulin	24 weeks	To evaluate the effect of 20 mg bexagliflozin on the change in HbA1c from baseline to week 24 in randomized subjects who have been prescribed insulin to control their diabetes

Trial Locations

Locations (157): Research Site 1079
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Hyattsville, Maryland, United States
Research Site 1219
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Somerset, New Jersey, United States
Research Site 1059
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Brooksville, Florida, United States
Research Site 1066
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Tampa, Florida, United States
Research Site 1050
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Panama City, Florida, United States
Research Site 1082
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Pocatello, Idaho, United States
Research Site 1223
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Midland, Michigan, United States
Research Site 1228
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Annapolis, Maryland, United States
Research Site 1217
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Petoskey, Michigan, United States
Research Site 1052
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Omaha, Nebraska, United States
Research Site 1254
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Ypsilanti, Michigan, United States
Research Site 5014
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Toronto, Ontario, Canada
Research Site 5023
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London, Ontario, Canada
Research Site 5005
🇨🇦
Sudbury, Ontario, Canada
Research Site 5015
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Cambridge, Ontario, Canada
Research Site 5016
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Peterborough, Ontario, Canada
Research Site 5008
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Gatineau, Quebec, Canada
Research Site 5006
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Quebec, Canada
Research Site 5009
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St. Georges, Quebec, Canada
Research Site 5007
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St-Charles-Borromee, Quebec, Canada
Research Site 2012
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Merida, Yucatan, Mexico
Research Site 2011
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Aguascalientes, Mexico
Research Site 2008
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Tampico, Tamaulipas, Mexico
Research Site 7001
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Wonju, Gangwon-Do, Korea, Republic of
Research Site 7002
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Gwangju, Korea, Republic of
Research Site 7008
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Incheon, Korea, Republic of
Research Site 2015
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Guadalajara, Jalisco, Mexico
Research Site 2009
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Chihuahua, Mexico
Research Site 2014
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Mexico, Mexico
Research Site 5110
🇳🇱
Amsterdam, Netherlands
Research Site 5101
🇳🇱
Hertogenbosch, Netherlands
Research Site 5112
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Hoofddorp, Netherlands
Research Site 5106
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Rotterdam, Netherlands
Research Site 7113
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Gdansk, Poland
Research Site 7119
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Gdynia, Poland
Research Site 7109
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Grodzisk Mazowiecki, Poland
Research Site 7121
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Katowice, Poland
Research Site 7135
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Lodz, Poland
Research Site 7120
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Lublin, Poland
Research Site 7108
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Olawa, Poland
Research Site 7118
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Otwock, Poland
Research Site 9303
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Moscow, Russian Federation
Research Site 7107
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Pulawy, Poland
Research Site 9309
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Lomonosov, Russian Federation
Research Site 9318
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Novosibirsk, Russian Federation
Research Site 7105
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Sobotka, Poland
Research Site 7112
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Sochaczew, Poland
Research Site 7123
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Warsaw, Poland
Research Site 9314
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Novosibirsk, Russian Federation
Research Site 9301
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Novosibirsk, Russian Federation
Research Site 9310
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Saint Petersburg, Russian Federation
Research Site 9304
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Saint Petersburg, Russian Federation
Research Site 9307
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Saint Petersburg, Russian Federation
Research Site 9311
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Saint Petersburg, Russian Federation
Research Site 8004
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Taipei, Taiwan
Research Site 8003
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Taipei, Taiwan
Research Site 1057
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Boca Raton, Florida, United States
Research Site 1090
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Gilbert, Arizona, United States
Research Site 1252
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Kalispell, Montana, United States
Research Site 1221
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Baltimore, Maryland, United States
Research Site 3116
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Benesov, Czechia
Research Site 3118
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Brno, Czechia
Research Site 1078
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Fresno, California, United States
Research Site 1073
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Azusa, California, United States
Research Site 1051
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Los Angeles, California, United States
Research Site 1041
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Little Rock, Arkansas, United States
Research Site 1216
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Norwalk, Connecticut, United States
Research Site 1259
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Dallas, Texas, United States
Research Site 1264
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Bronx, New York, United States
Research Site 1074
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Charlotte, North Carolina, United States
Research Site 1060
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Saint Louis, Missouri, United States
Research Site 3114
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Havirov, Czechia
Research Site 3105
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Marianske Lazne, Czechia
Research Site 3104
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Praha, Czechia
Research Site 3111
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Praha, Czechia
Research Site 1258
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Champaign, Illinois, United States
Research Site 1070
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Lampasas, Texas, United States
Research Site 1081
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North Richland Hills, Texas, United States
Research Site 1265
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Oklahoma City, Oklahoma, United States
Research Site 1071
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Avon, Indiana, United States
Research Site 1055
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Oklahoma City, Oklahoma, United States
Research Site 1043
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Anderson, Indiana, United States
Research Site 1224
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Covington, Kentucky, United States
Research Site 6105
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Copenhagen, Denmark
Research Site 3103
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Hradec Kralove, Czechia
Research Site 1229
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Wilmington, North Carolina, United States
Research Site 6104
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Copenhagen, Denmark
Research Site 3113
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Plzen, Czechia
Research Site 1222
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Lewisville, Texas, United States
Research Site 5012
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Hamilton, Ontario, Canada
Research Site 3106
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Brandys nad Labem, Czechia
Research Site 3115
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Uherske Hradiste, Czechia
Research Site 3112
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Praha, Czechia
Research Site 3109
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Cesky Krumlov, Czechia
Research Site 3102
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Kromeriz, Czechia
Research Site 3110
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Krnov, Czechia
Research Site 5113
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Harderwijk, Netherlands
Research Site 7122
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Aleksandrow Lodzki, Poland
Research Site 7111
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Kutno, Poland
Research Site 7117
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Warszawa, Poland
Research Site 8001
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Kaohsiung, Taiwan
Research Site 5102
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Hoogeveen, Netherlands
Research Site 5103
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Zwijndrecht, Netherlands
Research Site 7116
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Warszawa, Poland
Research Site 9302
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Tomsk, Russian Federation
Research Site 8006
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Taichung, Taiwan
Research Site 1075
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Fargo, North Dakota, United States
Research Site 1218
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Denver, Colorado, United States
Research Site 2013
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Culiacan, Sinaloa, Mexico
Research Site 1080
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Las Vegas, Nevada, United States
Research Site 1226
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San Antonio, Texas, United States
Research Site 1053
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San Antonio, Texas, United States
Research Site 1063
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Salt Lake City, Utah, United States
Research Site 1089
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Harbor City, California, United States
Research Site 1058
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Lincoln, California, United States
Research Site 1004
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Los Angeles, California, United States
Research Site 1077
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Orange, California, United States
Research Site 1068
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Montclair, California, United States
Research Site 1092
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Golden, Colorado, United States
Research Site 1083
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Newark, Delaware, United States
Research Site 1099
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Port Charlotte, Florida, United States
Research Site 1072
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Augusta, Georgia, United States
Research Site 1086
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Des Moines, Iowa, United States
Research Site 1054
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Saint Louis, Missouri, United States
Research Site 1263
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Omaha, Nebraska, United States
Research Site 1049
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West Seneca, New York, United States
Research Site 1044
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Albuquerque, New Mexico, United States
Research Site 1220
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Saratoga Springs, New York, United States
Research Site 1056
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Morehead City, North Carolina, United States
Research Site 1266
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Lindsay, Oklahoma, United States
Research Site 1042
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Cumberland, Rhode Island, United States
Research Site 1260
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Lancaster, Pennsylvania, United States
Research Site 1048
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Kingwood, Texas, United States
Research Site 1230
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Salem, Virginia, United States
Research Site 5013
🇨🇦
Vancouver, British Columbia, Canada
Research Site 5022
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Toronto, Ontario, Canada
Research Site 3107
🇨🇿
Brno, Czechia
Research Site 6103
🇩🇰
Copenhagen, Denmark
Research Site 7007
🇰🇷
Chuncheon, Gangwon-Do, Korea, Republic of
Research Site 7004
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Anyang, Gyeonggi-do, Korea, Republic of
Research Site 7005
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Guri, Gyeonggi-do, Korea, Republic of
Research Site 7006
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Busan, Korea, Republic of
Research Site 2016
🇲🇽
Queretaro, Mexico
Research Site 2010
🇲🇽
Veracruz, Mexico
Research Site 7115
🇵🇱
Katowice, Poland
Research Site 7106
🇵🇱
Katowice, Poland
Research Site 7104
🇵🇱
Lodz, Poland
Research Site 9315
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Moscow, Russian Federation
Research Site 9312
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Saint Petersburg, Russian Federation
Research Site 8002
🇨🇳
New Taipei, Taiwan
Research Site 8005
🇨🇳
Tainan, Taiwan
Research Site 8007
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Taipei, Taiwan
Research Site 1076
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Concord, California, United States
Research Site 1085
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Chapel Hill, North Carolina, United States
Research Site 1064
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Winston-Salem, North Carolina, United States
Research Site 1046
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Oklahoma City, Oklahoma, United States
Research Site 1225
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Austin, Texas, United States