Clinical trial NCT03358147: Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma
Official title: A Randomized, Double-Blind, Parallel Group, Multi-Center 24-Week Study Comparing the Efficacy and Safety of Three Doses of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Asthma
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-30
Enrollment: 1077
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Linear repeated measures model
Primary purpose: TREATMENT

Brief summary: Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma

Detailed description: A Randomized, Double-Blind, Parallel Group, Multi-Center 24-Week Study Comparing the Efficacy and Safety of Three Doses of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma

Eligibility criteria: Inclusion Criteria:

* Have a documented history of physician-diagnosed asthma
* Require inhaled asthma maintenance therapy: has been regularly using an ICS/LABA on a stable regimen for at least 4 weeks
* Documented reversibility to albuterol
* A pre-bronchodilator FEV1 \>40% and \<85% of predicted normal value for subjects 18 to 80 years of age or \>40% and \<90% of predicted for subjects 12 to \<18 years of age
* Demonstrate acceptable spirometry performance
* Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol
* Compliance: must be willing to remain at the study center as required per protocol to complete all visit assessments

Exclusion Criteria:

* Oral corticosteroid use (any dose) within 4 weeks
* Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months (including all forms of tobacco, e-cigarettes, and marijuana)
* Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
* Completed treatment for lower respiratory infection or asthma exacerbation within 4 weeks
* Hospitalizations for asthma within 3 months
* Historical or current evidence of a clinically significant disease
* Cancer not in complete remission for at least 5 years
* Treatment with investigational study drug (or device) in another clinical study within the last 30 days or 5 half-lives, whichever is longer
* Previously randomized in any PT001 study

Primary outcomes:
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 4 Hours (AUC0-4)
timeFrame: Week 24
Secondary outcomes:
measure: Change From Baseline in Morning Pre-dose Trough FEV1
timeFrame: Week 24
measure: Rate of Moderate to Severe Asthma Exacerbations
timeFrame: over 24 Weeks (timepoints of 4, 12 & 20 weeks)
measure: Change From Baseline in ACQ-7 (Asthma Control Questionnaire)
timeFrame: Week 24
measure: Change From Baseline in ACQ-5 (Asthma Control Questionnaire)
timeFrame: Week 24
measure: Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12)
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Dothan
country: United States
facility: Research Site
state: Alabama
city: Guntersville
country: United States
facility: Research Site
state: Alabama
city: Jasper
country: United States
facility: Research Site
state: Alabama
city: Scottsboro
country: United States
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state: Alabama
city: Chandler
country: United States
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state: Arizona
city: Flagstaff
country: United States
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state: Arizona
city: Phoenix
country: United States
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state: Arizona
city: Tempe
country: United States
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state: Arizona
city: Tucson
country: United States
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state: Arizona
city: Tucson
country: United States
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state: Arizona
city: Little Rock
country: United States
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state: Arkansas
city: Little Rock
country: United States
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state: Arkansas
city: Little Rock
country: United States
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state: Arkansas
city: Anaheim
country: United States
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state: California
city: Bakersfield
country: United States
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state: California
city: Corona
country: United States
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state: California
city: Costa Mesa
country: United States
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city: El Cajon
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state: California
city: Encinitas
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state: California
city: Fresno
country: United States
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state: California
city: Fullerton
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city: Gold River
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state: California
city: Huntington Beach
country: United States
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state: California
city: Long Beach
country: United States
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state: California
city: Long Beach
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state: California
city: Los Angeles
country: United States
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city: Los Angeles
country: United States
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city: Mission Viejo
country: United States
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city: Newport Beach
country: United States
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city: North Hollywood
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city: Northridge
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city: Orange
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city: Palmdale
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city: Rancho Mirage
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city: Riverside
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city: Rolling Hills Estates
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city: Sacramento
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city: Sacramento
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city: Sacramento
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city: San Diego
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city: San Diego
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city: San Diego
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city: San Diego
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city: San Jose
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city: Stockton
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city: Thousand Oaks
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city: Tustin
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city: Westminster
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city: Centennial
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state: Colorado
city: Colorado Springs
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city: Colorado Springs
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city: Lafayette
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state: Connecticut
city: Aventura
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city: Brandon
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city: Clearwater
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city: Clearwater
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city: Gainesville
country: United States
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city: Hialeah
country: United States
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city: Hialeah
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city: Hialeah
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city: Kissimmee
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city: Lake City
country: United States
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city: Loxahatchee Groves
country: United States
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city: Miami
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
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city: Miami
country: United States
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city: Miami
country: United States
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state: Florida
city: Ocala
country: United States
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state: Florida
city: Ocoee
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Panama City
country: United States
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city: Pembroke Pines
country: United States
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state: Florida
city: Saint Cloud
country: United States
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state: Florida
city: Tallahassee
country: United States
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state: Florida
city: Tampa
country: United States
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state: Florida
city: Winter Park
country: United States
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state: Florida
city: Adairsville
country: United States
facility: Research Site
state: Georgia
city: Albany
country: United States
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state: Georgia
city: Atlanta
country: United States
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state: Georgia
city: Columbus
country: United States
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state: Georgia
city: Dacula
country: United States
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state: Georgia
city: Gainesville
country: United States
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state: Georgia
city: Lawrenceville
country: United States
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state: Georgia
city: Norcross
country: United States
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state: Georgia
city: Rincon
country: United States
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state: Georgia
city: Savannah
country: United States
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state: Georgia
city: Stockbridge
country: United States
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state: Georgia
city: Boise
country: United States
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state: Idaho
city: Meridian
country: United States
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state: Idaho
city: Evergreen Park
country: United States
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state: Illinois
city: O'Fallon
country: United States
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state: Illinois
city: River Forest
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city: Brownsburg
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state: Indiana
city: Michigan City
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city: Fort Mitchell
country: United States
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city: Crowley
country: United States
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state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Zachary
country: United States
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state: Louisiana
city: Bangor
country: United States
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state: Maine
city: Chevy Chase
country: United States
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state: Maryland
city: White Marsh
country: United States
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state: Maryland
city: Fall River
country: United States
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state: Massachusetts
city: North Dartmouth
country: United States
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state: Massachusetts
city: Ann Arbor
country: United States
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state: Michigan
city: Farmington Hills
country: United States
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state: Michigan
city: Rochester
country: United States
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state: Michigan
city: Troy
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state: Michigan
city: Edina
country: United States
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state: Minnesota
city: Fridley
country: United States
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state: Minnesota
city: Minneapolis
country: United States
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state: Minnesota
city: Minneapolis
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city: Woodbury
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state: Minnesota
city: Chesterfield
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state: Missouri
city: Columbia
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state: Missouri
city: Saint Charles
country: United States
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state: Missouri
city: Saint Louis
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state: Missouri
city: Bellevue
country: United States
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state: Nebraska
city: Bellevue
country: United States
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state: Nebraska
city: Lincoln
country: United States
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state: Nebraska
city: Omaha
country: United States
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state: Nebraska
city: Las Vegas
country: United States
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state: Nevada
city: Las Vegas
country: United States
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state: Nevada
city: Las Vegas
country: United States
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state: Nevada
city: Reno
country: United States
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state: Nevada
city: Berlin
country: United States
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state: New Jersey
city: Ocean City
country: United States
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state: New Jersey
city: Skillman
country: United States
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state: New Jersey
city: Toms River
country: United States
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state: New Jersey
city: Albuquerque
country: United States
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state: New Mexico
city: Albuquerque
country: United States
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state: New Mexico
city: Bronx
country: United States
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state: New York
city: Bronx
country: United States
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state: New York
city: Cortland
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Watertown
country: United States
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state: New York
city: Burlington
country: United States
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state: North Carolina
city: Charlotte
country: United States
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state: North Carolina
city: Charlotte
country: United States
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state: North Carolina
city: Elizabeth City
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state: North Carolina
city: Gastonia
country: United States
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state: North Carolina
city: Greensboro
country: United States
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state: North Carolina
city: Hickory
country: United States
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state: North Carolina
city: Huntersville
country: United States
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state: North Carolina
city: Monroe
country: United States
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state: North Carolina
city: Mooresville
country: United States
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state: North Carolina
city: New Bern
country: United States
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state: North Carolina
city: Raleigh
country: United States
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state: North Carolina
city: Winston-Salem
country: United States
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state: North Carolina
city: Fargo
country: United States
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state: North Dakota
city: Fargo
country: United States
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state: North Dakota
city: Cincinnati
country: United States
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state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Columbus
country: United States
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city: Dayton
country: United States
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state: Ohio
city: Dayton
country: United States
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state: Ohio
city: Dublin
country: United States
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state: Ohio
city: Marion
country: United States
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state: Ohio
city: Wooster
country: United States
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state: Ohio
city: Edmond
country: United States
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state: Oklahoma
city: Oklahoma City
country: United States
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state: Oklahoma
city: Tulsa
country: United States
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state: Oklahoma
city: Clackamas
country: United States
facility: Research Site
state: Oregon
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Monroeville
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Wyomissing
country: United States
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state: Pennsylvania
city: East Providence
country: United States
facility: Research Site
state: Rhode Island
city: Warwick
country: United States
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state: Rhode Island
city: Anderson
country: United States
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state: South Carolina
city: Charleston
country: United States
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state: South Carolina
city: Gaffney
country: United States
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state: South Carolina
city: Gaffney
country: United States
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state: South Carolina
city: Greenville
country: United States
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state: South Carolina
city: Hodges
country: United States
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state: South Carolina
city: Mount Pleasant
country: United States
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state: South Carolina
city: Myrtle Beach
country: United States
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state: South Carolina
city: Rock Hill
country: United States
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state: South Carolina
city: Spartanburg
country: United States
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state: South Carolina
city: Spartanburg
country: United States
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state: South Carolina
city: Union
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state: South Carolina
city: Rapid City
country: United States
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state: South Dakota
city: Franklin
country: United States
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state: Tennessee
city: Hendersonville
country: United States
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state: Tennessee
city: Johnson City
country: United States
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state: Tennessee
city: Smyrna
country: United States
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state: Tennessee
city: Amarillo
country: United States
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state: Texas
city: Austin
country: United States
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state: Texas
city: Boerne
country: United States
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state: Texas
city: Carrollton
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: El Paso
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Kerrville
country: United States
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state: Texas
city: Killeen
country: United States
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state: Texas
city: Lampasas
country: United States
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state: Texas
city: Live Oak
country: United States
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state: Texas
city: Lufkin
country: United States
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state: Texas
city: Pearland
country: United States
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state: Texas
city: Plano
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Sherman
country: United States
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state: Texas
city: Tomball
country: United States
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state: Texas
city: Waco
country: United States
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state: Texas
city: Murray
country: United States
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state: Utah
city: Salt Lake City
country: United States
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state: Utah
city: Salt Lake City
country: United States
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state: Utah
city: South Burlington
country: United States
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state: Vermont
city: Abingdon
country: United States
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state: Virginia
city: Newport News
country: United States
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state: Virginia
city: Richmond
country: United States
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state: Virginia
city: Richmond
country: United States
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state: Virginia
city: Bellingham
country: United States
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state: Washington
city: Spokane Valley
country: United States
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state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
city: Greenfield
country: United States
facility: Research Site
state: Wisconsin
Study officials:
References: