Observational Study of Characteristics, Treatment and Outcomes With Severe Asthma in the United States (CHRONICLE)

Last updated: September 22, 2025
Sponsor: AstraZeneca
Overall Status: Completed

Phase

N/A

Condition

Asthma

Treatment

N/A

Clinical Study ID

NCT03373045
D3250R00023
  • Ages 18-130
  • All Genders

Study Summary

The CHRONICLE Study is a multi-center, non-interventional, prospective cohort study of adults with severe asthma who do not achieve control with high-dose inhaled corticosteroid (ICS) therapy with additional controllers and/or require systemic corticosteroid or monoclonal antibody therapy. Data will be collected from the healthcare provider in a uniform manner for every patient enrolled using an electronic case report form (eCRF). Data will be collected monthly from patients via web-based surveys. Patients will be followed until study discontinuation or the patient withdraws from the study or death, whichever occurs first. The expectation is that patients will be followed for a period of at least 3 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Individuals with a diagnosis of severe asthma for at least 12 months prior to enrollment and confirmed by the Investigator not to be due to alternative diagnoses.

  2. Currently receiving care from specialist physicians (eg, pulmonologists and or allergists) at the Investigator's or sub-investigator's site.

  3. 18 years of age and older. 4. Meeting at least one of the following three criteria (a, b, or c):

a. Uncontrolled asthma while receiving high-dose ICS with additional controllers.

i. Uncontrolled is defined by meeting at least one of the following (as outlined by ATS/ERS [American Thoracic Society/European Respiratory Society] guidelines):

  1. Poor symptom control: Asthma Control Questionnaire consistently ≥1.5, ACT <20 (or "not well controlled" by NAEPP [National Asthma Education and Prevention Program]/Global Initiative for Asthma guidelines).

  2. Frequent severe exacerbations: two or more bursts of systemic corticosteroids (≥3 days each) in the previous 12 months.

  3. Serious exacerbations: at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous 12 months.

  4. Airflow limitation: after appropriate bronchodilator withhold FEV1 <80% predicted (in the face of reduced FEV1/FVC defined as less than the lower limit of normal).

ii. For the purposes of this study, high-dose ICS will be defined as

  1. ICS at a cumulative dose of >500 μg fluticasone propionate equivalents daily as defined in Appendix A, or 2. Highest labeled dose of a combination of ICS/LABA. b. Current use of a Food and Drug Administration (FDA)-approved monoclonal antibody agent for treatment of severe asthma (use is not primarily for an alternative condition).

c. Use of systemic corticosteroids or other systemic immunosuppressants (any dose level) for approximately 50% or more of the prior 12 months for treatment of severe asthma (use is not primarily for an alternative condition).

Exclusion Criteria

  1. Not willing and able to sign written informed consent. Consent can be obtained from having a responsible, legally authorized representative acting on patient's behalf.

  2. Not fluent in English or Spanish.

  3. Inability to complete study follow-up or web-based PROs. If the patient does not have email or web access, minimal assistance from others to access the web-based PRO is permitted (ie receiving the email and/or assisting patient in navigating to the web page); PROs must be completed by the patient.

  4. Received an investigational therapy for asthma, allergy, atopic disease, or eosinophilic disease as part of a clinical trial during the 6 months prior to enrollment.

  5. Once enrolled in the CHRONICLE Study, patients can enroll in trials of investigational therapies (as well as other non-interventional studies) as long as they continue to complete study follow-up. If a patient enrolls in a trial of an investigational therapy, the identity (National Clinical Trial [NCT] number) of the study and dates of the first and last investigational therapy administrations will be collected. If a patient receives blinded therapy in a trial, the Investigator will request the identity of that therapy at trial conclusion so that treatment information collected for the current study may be updated accordingly.

Study Design

Total Participants: 18
Study Start date:
February 27, 2018
Estimated Completion Date:
February 14, 2025

Study Description

The CHRONICLE Study is a multi-center, non-interventional, prospective cohort study of adults with severe asthma who do not achieve control with high-dose ICS therapy with additional controllers and/or require systemic corticosteroid or monoclonal antibody therapy. This study will provide a contemporary description of the epidemiology and medical management of United States adults with severe asthma who have not achieved control with high-dose ICS therapy and additional controllers. Additionally, the study will describe the use of and outcomes associated with recently approved monoclonal antibody therapies for severe asthma. Patients will be enrolled from a diverse population of academic and community-based specialist centers across the US. Data will be collected in a naturalistic manner and patient management will not be influenced by the study protocol. At least 1500 patients in the US with a confirmed diagnosis of severe asthma will be enrolled by a diverse set of asthma specialists (eg, allergists and pulmonologists who treat asthma) from academic and community-based centers. Basic de-identified information will be collected for all patients meeting study inclusion criteria, including those not approached for enrollment or who decline enrollment, to enable an assessment of the enrolled and non-enrolled populations. This information will include age, sex, insurance status, age at asthma diagnosis, class of asthma treatment per study inclusion criteria, number of asthma exacerbations in the past 12 months, study eligibility, whether the patient was approached for enrollment, study enrollment status, and reason for not enrolling for those who are approached but do not enroll. Patient-reported asthma control (Asthma Control Test [ACT]), asthma exacerbations, and treatment adherence will be solicited monthly. Patient-reported information on asthma-related healthcare utilization, global evaluation of treatment effectiveness (GETE), and work productivity (Work Productivity and Activity Impairment Asthma questionnaire [WPAI-Asthma]) will be collected at baseline and approximately every 3 months. Detailed information on asthma-related quality of life (Saint George's Respiratory Questionnaire [SGRQ]) as well as presence of an asthma treatment plan will be collected from patients approximately every 6 months. All of the questionnaires will be collected via web-based surveys. Patients will then be followed until study discontinuation or the patient withdraws from the study or death, whichever occurs first. The expectation is that patients will be followed for a period of at least 3 years.

Connect with a study center

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    Guaynabo, 00968
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    Guaynabo 4565119, 00968
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    Birmingham, Alabama 35294
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    Hoover, Alabama 35244
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    Birmingham 4049979, Alabama 4829764 35294
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    Hoover 4067994, Alabama 4829764 35244
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    Gilbert, Arizona 85234
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    Peoria, Arizona 85381
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    Gilbert 5295903, Arizona 5551752 85234
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    Peoria 5308480, Arizona 5551752 85381
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    Little Rock, Arkansas 72205
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    Little Rock 4119403, Arkansas 4099753 72205
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    Bakersfield, California 93301
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    Loma Linda, California 92354
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    Los Angeles, California 90025
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    Mission Viejo, California 92691
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    Modesto, California 95355-4201
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    Redondo Beach, California 90277
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    Riverside, California 92506
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    Roseville, California 95661
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    Sacramento, California 95819
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    San Diego, California 92130-3318
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    Santa Monica, California 90404
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    Studio City, California 91607
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    Ventura, California 93003
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    Westminster, California 92683
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    Bakersfield 5325738, California 5332921 93301
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    Loma Linda 5367696, California 5332921 92354
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    Los Angeles 5368361, California 5332921 90025
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    Mission Viejo 5373763, California 5332921 92691
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    Modesto 5373900, California 5332921 95355-4201
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    Redondo Beach 5386785, California 5332921 90277
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    Riverside 5387877, California 5332921 92506
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    Roseville 5388881, California 5332921 95661
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    Sacramento 5389489, California 5332921 95819
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    San Diego 5391811, California 5332921 92123
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    Santa Monica 5393212, California 5332921 90404
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    Studio City 5399438, California 5332921 91607
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    Ventura 5405878, California 5332921 93003
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    Westminster 5408406, California 5332921 92683
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    Aurora, Colorado 80045
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    Aurora 5412347, Colorado 5417618 80045
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    Danbury, Connecticut 06810
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    Farmington, Connecticut 06030
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    New Haven, Connecticut 06510
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    Waterbury, Connecticut 06708
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    Danbury 4832353, Connecticut 4831725 06810
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    Farmington 4834272, Connecticut 4831725 06030
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    New Haven 4839366, Connecticut 4831725 06510
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    Waterbury 4845193, Connecticut 4831725 06708
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    Newark, Delaware 19713
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    Newark 4143861, Delaware 4142224 19713
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    Brandon, Florida 33511
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    Clearwater, Florida 33765
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    Coral Gables, Florida 33134
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    Gainesville, Florida 32608
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    Jacksonville, Florida 32204
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    Kissimmee, Florida 34759
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    Lake Mary, Florida 32746
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    Miami, Florida 33032
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    Miami Beach, Florida 33140
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    Pensacola, Florida 32504
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    Plantation, Florida 33317
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    Saint Petersburg, Florida 33704
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    Tallahassee, Florida 32308
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    Tampa, Florida 32789
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    Brandon 4148757, Florida 4155751 33511
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    Clearwater 4151316, Florida 4155751 33765
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    Coral Gables 4151871, Florida 4155751 33134
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    Jacksonville 4160021, Florida 4155751 32204
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    Kissimmee 4160983, Florida 4155751 34759
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    Lake Mary 4161373, Florida 4155751 32746
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    Miami 4164138, Florida 4155751 33175
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    Miami Beach 4164143, Florida 4155751 33140
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    Pensacola 4168228, Florida 4155751 32504
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    Plantation 4168782, Florida 4155751 33317
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    St. Petersburg 4171563, Florida 4155751 33704
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    Tallahassee 4174715, Florida 4155751 32308
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    Tampa 4174757, Florida 4155751 32789
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    Albany, Georgia 31707
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    Decatur, Georgia 30033
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    Villa Rica, Georgia 30180
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    Albany 4179320, Georgia 4197000 31707
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    Decatur 4191124, Georgia 4197000 30033
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    Gainesville 4196586, Georgia 4197000 30501
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    Villa Rica 4228452, Georgia 4197000 30180
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    Boise, Idaho 83706
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    Boise 5586437, Idaho 5596512 83706
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    Chicago, Illinois 60611
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    Glen Ellyn, Illinois 60137
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    Chicago 4887398, Illinois 4896861 60611
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    Glen Ellyn 4893811, Illinois 4896861 60137
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    Fort Wayne, Indiana 46804
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    Fort Wayne 4920423, Indiana 4921868 46804
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    Iowa City, Iowa 52242
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    West Des Moines, Iowa 50266
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    Iowa City 4862034, Iowa 4862182 52242
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    West Des Moines 4881346, Iowa 4862182 50266
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    Overland Park, Kansas 66210
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    Overland Park 4276873, Kansas 4273857 66210
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    Georgetown, Kentucky 40324
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    Lexington, Kentucky 40503
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    Louisville, Kentucky 40215
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    Georgetown 4292686, Kentucky 6254925 40324
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    Lexington 4297983, Kentucky 6254925 40509
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    Louisville 4299276, Kentucky 6254925 40215
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    New Orleans, Louisiana 70112
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    Shreveport, Louisiana 71106
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    New Orleans 4335045, Louisiana 4331987 70127
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    Shreveport 4341513, Louisiana 4331987 71106
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    Bangor, Maine 04401
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    Bangor 4957280, Maine 4971068 04401
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    Rockville, Maryland 20850
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    Silver Spring, Maryland 20902
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    Upper Marlboro, Maryland 20772
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    Wheaton, Maryland 20902
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    Rockville 4367175, Maryland 4361885 20850
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    Silver Spring 4369596, Maryland 4361885 20902
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    Burlington, Massachusetts 07805
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    North Dartmouth, Massachusetts 02747
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    Burlington 4931737, Massachusetts 6254926 01805
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    North Dartmouth 4945601, Massachusetts 6254926 02747
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    Ann Arbor, Michigan 48106
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    Clinton Township, Michigan 48038
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    Detroit, Michigan 48202
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    Flint, Michigan 48532
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    Hamtramck, Michigan 48211
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    Wyoming, Michigan 49519
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    Ann Arbor 4984247, Michigan 5001836 48109
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    Clinton Township 4989133, Michigan 5001836 48038
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    Detroit 4990729, Michigan 5001836 48202
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    Hamtramck 4995197, Michigan 5001836 48211
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    Wyoming 5015618, Michigan 5001836 49519
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    Maplewood, Minnesota 55109
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    Minneapolis, Minnesota 55455
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    Plymouth, Minnesota 55402
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    Maplewood 5036588, Minnesota 5037779 55109
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    Minneapolis 5037649, Minnesota 5037779 55455
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    Plymouth 5041926, Minnesota 5037779 55402
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    Rochester 5043473, Minnesota 5037779 55905
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    Saint Louis, Missouri 63110
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    St Louis 4407066, Missouri 4398678 63110
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    Bellevue, Nebraska 68123
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    Omaha, Nebraska 68105
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    Lincoln 5072006, Nebraska 5073708 68505
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    Omaha 5074472, Nebraska 5073708 68124
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    Las Vegas, Nevada 89106
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    Las Vegas 5506956, Nevada 5509151 89106
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    Brick, New Jersey 08724
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    Marlton, New Jersey 08053
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    New Brunswick, New Jersey 08901
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    North Bergen, New Jersey 07047
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    Northfield, New Jersey 08225
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    Toms River, New Jersey 08755
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    Verona, New Jersey 07044
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    Brick 5095947, New Jersey 5101760 08724
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    Marlton 4502911, New Jersey 5101760 08053
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    New Brunswick 5101717, New Jersey 5101760 08901
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    North Bergen 5101879, New Jersey 5101760 07047
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    Northfield 4503316, New Jersey 5101760 08225
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    Toms River 4504476, New Jersey 5101760 08755
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    Verona 5105809, New Jersey 5101760 07044
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    Albuquerque, New Mexico 87109
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    Albuquerque 5454711, New Mexico 5481136 87109
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    Bayside, New York 11361
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    Bronx, New York 10461
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    Brooklyn, New York 11230
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    Corning, New York 14830
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    Great Neck, New York 11023
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    Jamaica, New York 11418
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    Mineola, New York 11501
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    New Hyde Park, New York 11042
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    New Paltz, New York 12561
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    New York, New York 10022
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    Rochester, New York 14621
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    Rockville Centre, New York 11570
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    Staten Island, New York 10305
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    Valhalla, New York 10595
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    Bayside 5108193, New York 5128638 11361
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    Brooklyn 5110302, New York 5128638 11230
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    Corning 5113760, New York 5128638 14830
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    Great Neck 5119218, New York 5128638 11023
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    Jamaica 5122520, New York 5128638 11418
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    Mineola 5127134, New York 5128638 11501
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    New Hyde Park 5128514, New York 5128638 11042
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    New Paltz 5128539, New York 5128638 12561
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    New York 5128581, New York 5128638 10022
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    Rochester 5134086, New York 5128638 14642
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    Rockville Centre 5134203, New York 5128638 11570
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    Staten Island 5139568, New York 5128638 10305
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    The Bronx 5110266, New York 5128638 10458
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    Valhalla 5142090, New York 5128638 10595
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    Asheville, North Carolina 28801
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    Chapel Hill, North Carolina 27599
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    Charlotte, North Carolina 28277
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    Durham, North Carolina 27701
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    Fayetteville, North Carolina 28304
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    Greenville, North Carolina 27834
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    Winston-Salem, North Carolina 27157
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    Asheville 4453066, North Carolina 4482348 28801
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    Chapel Hill 4460162, North Carolina 4482348 27599
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    Charlotte 4460243, North Carolina 4482348 28204
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    Durham 4464368, North Carolina 4482348 27701
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    Fayetteville 4466033, North Carolina 4482348 28304
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    Greenville 4469160, North Carolina 4482348 27834
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    Winston-Salem 4499612, North Carolina 4482348 27157
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    Fargo, North Dakota 58104
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    Fargo 5059163, North Dakota 5690763 58104
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    Toledo, Ohio 43617
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    Toledo 5174035, Ohio 5165418 43617
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    Oklahoma City, Oklahoma 73131
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    Oklahoma City 4544349, Oklahoma 4544379 73120
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    Corvallis, Oregon 97330
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    Portland, Oregon 97220
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    Corvallis 5720727, Oregon 5744337 97330
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    Portland 5746545, Oregon 5744337 97225
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    Altoona, Pennsylvania 16601
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    Blue Bell, Pennsylvania 19422
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    DuBois, Pennsylvania 15801
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    Harrisburg, Pennsylvania 17109
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    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15241
    United States

    Site Not Available

  • Research Site

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Research Site

    Yardley, Pennsylvania 19067
    United States

    Site Not Available

  • Research Site

    Altoona 5178195, Pennsylvania 6254927 16601
    United States

    Site Not Available

  • Research Site

    Blue Bell 5180961, Pennsylvania 6254927 19422
    United States

    Site Not Available

  • Research Site

    DuBois 5187432, Pennsylvania 6254927 15801
    United States

    Site Not Available

  • Research Site

    Harrisburg 5192726, Pennsylvania 6254927 17109
    United States

    Site Not Available

  • Research Site

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Research Site

    Pittsburgh 5206379, Pennsylvania 6254927 15241
    United States

    Site Not Available

  • Research Site

    Sayre 5211037, Pennsylvania 6254927 18840
    United States

    Site Not Available

  • Research Site

    Yardley 5220281, Pennsylvania 6254927 19067
    United States

    Site Not Available

  • Research Site

    Lincoln, Rhode Island 02865
    United States

    Site Not Available

  • Research Site

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • Research Site

    Lincoln 8531960, Rhode Island 5224323 02865
    United States

    Site Not Available

  • Research Site

    Clinton, South Carolina 29325
    United States

    Site Not Available

  • Research Site

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Research Site

    North Charleston, South Carolina 29420
    United States

    Site Not Available

  • Research Site

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • Research Site

    Clinton 4575028, South Carolina 4597040 29325
    United States

    Site Not Available

  • Research Site

    Greenville 4580543, South Carolina 4597040 29607
    United States

    Site Not Available

  • Research Site

    Mt. Pleasant 4588165, South Carolina 4597040 29464
    United States

    Site Not Available

  • Research Site

    North Charleston 4589387, South Carolina 4597040 29420
    United States

    Site Not Available

  • Research Site

    Rock Hill 4593142, South Carolina 4597040 29732
    United States

    Site Not Available

  • Research Site

    Franklin, Tennessee 37064
    United States

    Site Not Available

  • Research Site

    Hendersonville, Tennessee 37075
    United States

    Site Not Available

  • Research Site

    Franklin 4623560, Tennessee 4662168 37064
    United States

    Site Not Available

  • Research Site

    Hendersonville 4628735, Tennessee 4662168 37075
    United States

    Site Not Available

  • Research Site

    Aransas Pass, Texas 78336
    United States

    Site Not Available

  • Research Site

    Beaumont, Texas 77702
    United States

    Site Not Available

  • Research Site

    Dallas, Texas 75246
    United States

    Site Not Available

  • Research Site

    Denison, Texas 75020
    United States

    Site Not Available

  • Research Site

    Duncanville, Texas 75116
    United States

    Site Not Available

  • Research Site

    Fort Worth, Texas 76107
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    Katy, Texas 77450
    United States

    Site Not Available

  • Research Site

    Kingwood, Texas 77339
    United States

    Site Not Available

  • Research Site

    Live Oak, Texas 78233
    United States

    Site Not Available

  • Research Site

    McKinney, Texas 75069
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78251
    United States

    Site Not Available

  • Research Site

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Research Site

    Aransas Pass 4671141, Texas 4736286 78336
    United States

    Site Not Available

  • Research Site

    Beaumont 4672989, Texas 4736286 77702
    United States

    Site Not Available

  • Research Site

    Dallas 4684888, Texas 4736286 75246
    United States

    Site Not Available

  • Research Site

    Denison 4685892, Texas 4736286 75020
    United States

    Site Not Available

  • Research Site

    Duncanville 4687331, Texas 4736286 75116
    United States

    Site Not Available

  • Research Site

    Fort Worth 4691930, Texas 4736286 76107
    United States

    Site Not Available

  • Research Site

    Houston 4699066, Texas 4736286 77079
    United States

    Site Not Available

  • Research Site

    Katy 4702732, Texas 4736286 77450
    United States

    Site Not Available

  • Research Site

    Kingwood 7534469, Texas 4736286 77339
    United States

    Site Not Available

  • Research Site

    Live Oak 4707055, Texas 4736286 78233
    United States

    Site Not Available

  • Research Site

    McKinney 4710178, Texas 4736286 75069
    United States

    Site Not Available

  • Research Site

    San Antonio 4726206, Texas 4736286 78251
    United States

    Site Not Available

  • Research Site

    Sugar Land 4734825, Texas 4736286 77478
    United States

    Site Not Available

  • Research Site

    Murray, Utah 84107
    United States

    Site Not Available

  • Research Site

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Research Site

    Murray 5778755, Utah 5549030 84107
    United States

    Site Not Available

  • Research Site

    Salt Lake City 5780993, Utah 5549030 84132
    United States

    Site Not Available

  • Research Site

    Lynchburg, Virginia 24501
    United States

    Site Not Available

  • Research Site

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Research Site

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Research Site

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Research Site

    Williamsburg, Virginia 23188
    United States

    Site Not Available

  • Research Site

    Lynchburg 4771075, Virginia 6254928 24501
    United States

    Site Not Available

  • Research Site

    Newport News 4776024, Virginia 6254928 23606
    United States

    Site Not Available

  • Research Site

    Norfolk 4776222, Virginia 6254928 23507
    United States

    Site Not Available

  • Research Site

    Richmond 4781708, Virginia 6254928 23229
    United States

    Site Not Available

  • Research Site

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Research Site

    Vancouver, Washington 98664
    United States

    Site Not Available

  • Research Site

    Tacoma 5812944, Washington 5815135 98405
    United States

    Site Not Available

  • Research Site

    Vancouver 5814616, Washington 5815135 98664
    United States

    Site Not Available

  • Research Site

    Charleston, West Virginia 25304
    United States

    Site Not Available

  • Research Site

    Charleston 4801859, West Virginia 4826850 25304
    United States

    Site Not Available

  • Research Site

    Greenfield, Wisconsin 53228
    United States

    Site Not Available

  • Research Site

    Madison, Wisconsin 53792-9988
    United States

    Site Not Available

  • Research Site

    Onalaska, Wisconsin 54650
    United States

    Site Not Available

  • Research Site

    Wausau, Wisconsin 54401
    United States

    Site Not Available

  • Research Site

    Greenfield 5255068, Wisconsin 5279468 53228
    United States

    Site Not Available

  • Research Site

    Madison 5261457, Wisconsin 5279468 53792-9988
    United States

    Site Not Available

  • Research Site

    Onalaska 5265702, Wisconsin 5279468 54650
    United States

    Site Not Available

  • Research Site

    Wausau 5278120, Wisconsin 5279468 54401
    United States

    Site Not Available

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