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Iressa Expanded Access Program (EAP)

Primary Purpose

Carcinoma, Non-small-cell Lung, Metastases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ZD1839 (Gefitinib)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma focused on measuring Locally advanced and/or metastatic non-operable, non-small cell lung cancer (stage III or IV), patients who have failed standard therapy.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria For inclusion in this trial, patients must fulfill all of the following criteria: previous documented histologically or cytologically confirmed non-small cell lung cancer; locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV)patients who have received at least one course of standard systemic chemotherapy or radiation therapy or are ineligible for chemotherapy or radiotherapy or are ineligible or not a candidate for enrollment on another ZD1839 trial or who, in the Investigator's opinion, are not medically suitable for chemotherapy. age 18 years or older; written informed consent to participate in the trial. Exclusion Criteria Any of the following will exclude a patient from entering the trial: receiving concurrent radiotherapy, chemotherapy, or other systemic anti-cancer medication or any other investigational agent. * Non-cytotoxic or hormonal therapies for the adjuvant treatment of cancer or for previously treated cancers may be allowed per AstraZeneca permission; patients eligible for or previously enrolled on a ZD1839 blinded clinical trial protocol. Patients eligible for or previously enrolled on an open-label or unblinded ZD1839 clinical trial may be considered for acceptance into the Expanded Access Program with AstraZeneca permission; having other active malignancies; incomplete healing from previous oncologic or other major surgery; evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial; pregnancy or breast feeding (women of child-bearing potential).

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Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2002
Last Updated
January 3, 2013
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00034879
Brief Title
Iressa Expanded Access Program (EAP)
Official Title
An Expanded Access Clinical Program With ZD1839 (IRESSA®) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A program for patients with non small cell lung cancer who may benefit from Iressa, but cannot enter another clinical trial due to them not being eligible, or for whom no trials are available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-small-cell Lung, Metastases, Neoplasm
Keywords
Locally advanced and/or metastatic non-operable, non-small cell lung cancer (stage III or IV), patients who have failed standard therapy.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ZD1839 (Gefitinib)
Other Intervention Name(s)
Iressa

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria For inclusion in this trial, patients must fulfill all of the following criteria: previous documented histologically or cytologically confirmed non-small cell lung cancer; locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV)patients who have received at least one course of standard systemic chemotherapy or radiation therapy or are ineligible for chemotherapy or radiotherapy or are ineligible or not a candidate for enrollment on another ZD1839 trial or who, in the Investigator's opinion, are not medically suitable for chemotherapy. age 18 years or older; written informed consent to participate in the trial. Exclusion Criteria Any of the following will exclude a patient from entering the trial: receiving concurrent radiotherapy, chemotherapy, or other systemic anti-cancer medication or any other investigational agent. * Non-cytotoxic or hormonal therapies for the adjuvant treatment of cancer or for previously treated cancers may be allowed per AstraZeneca permission; patients eligible for or previously enrolled on a ZD1839 blinded clinical trial protocol. Patients eligible for or previously enrolled on an open-label or unblinded ZD1839 clinical trial may be considered for acceptance into the Expanded Access Program with AstraZeneca permission; having other active malignancies; incomplete healing from previous oncologic or other major surgery; evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial; pregnancy or breast feeding (women of child-bearing potential).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iressa Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
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Alabaster
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Alabama
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United States
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Anniston
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Birmingham
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Gadsen
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Huntsville
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Scottsdale
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Sedona
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Tucson
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Yuma
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Campbell
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Chico
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Chino
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Concord
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Gilroy
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Greenbrae
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La Jolla
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Newport Beach
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Oakland
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Orange
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Oxnard
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Palm Springs
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Palo Alto
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Panorama City
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Petaluma
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Pleasanton
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Rancho Mirage
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Redding
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Redondo Beach
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Riverside
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Royal Grande
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Salinas
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San Diego
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San Francisco
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San Jose
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San Luis Obispo
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San Mateo
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Santa Barbara
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Santa Clara
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Santa Cruz
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Santa Maria
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Santa Monica
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Simi Valley
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Soquel
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Stockton
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Sunnyvale
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Sylmar
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Tarzana
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Thousand Oaks
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Twentynine Palm
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Upland
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Vallejo
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Van Nuys
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Walnut Creek
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Woodland Hills
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Boulder
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Longmont
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Handen
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Hartford
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Torrington
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Trumbull
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Waterbury
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Washington
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Clearwater
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Key West
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Miami Shores
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Miami
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City
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City
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Ocala
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Orlando
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Panama City
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Plantation
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Port Charlotte
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Sanford
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Sarasota
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St. Augustine
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Stuart
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Tampa
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Tavares
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City
Vero Beach
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West Palm Beach
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Atlanta
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Fort Gordon
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Macon
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Marietta
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Savannah
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Thomasville
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Tucker
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City
Valdosta
State/Province
Georgia
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Way Cross
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Honolulu
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Wailuku
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Boise
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Chicago Heights
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Chicago
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Danville
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Harvey
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Moline
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Peoria
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Rockford
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Zion
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Ames
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Bettendorf
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Waterloo
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Hays
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Lenexa
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York
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Springfield
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Stoneham
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Grand Rapids
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Grosse Point Woods
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Iron Mountain
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Jackson
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Kalamazoo
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Lansing
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Lapeer
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Marquette
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Midland
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Mount Clemens
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Muskegon
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Port Huron
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Roseville
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Royal Oak
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Southfield
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St Joseph
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Traverse City
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Roseville
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St Louis
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St. Louis
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Billings
State/Province
Montana
Country
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Great Falls
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Helena
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Grand Island
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Lincoln
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City
Omaha
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Hooksett
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Lebanon
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Nashua
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Denville
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City
Elizabeth
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City
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Little Silver
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Livingston
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Long Branch
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Mahwah
State/Province
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New Brunswick
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Newark
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Old Bridge
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Paramus
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City
Phillipsburg
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City
Plainfield
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City
Pompton Plains
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Princeton
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Red Bank
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Somerset
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Summit
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Teaneck
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Union
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Voorhees
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Westwood
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City
Albuquerque
State/Province
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City
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City
Las Cruces
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City
Roswell
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City
Santa Fe
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City
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Bronxville
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Bronx
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City
Brooklyn
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City
Buffalo
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City
Cooperstown
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City
E Syracuse
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City
East Setauket
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Flushing
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Fresh Meadows
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City
Geneseo
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Glen Cove
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Glens Falls
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Goshen
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Great Neck
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Harris
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Huntington Station
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City
Huntington
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Johnson City
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Lake Success
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Malone
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Merrick
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Mineola
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New Hyde Park
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New Rochelle
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City
New York
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New York
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United States
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North Port
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City
Nyack
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City
Pomona
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Port Washington
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Riverhead
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Rochester
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Rockville Centre
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City
Schenectady
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Staten Island
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Suffern
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Syosset
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Utica
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Valhalla
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Valley Stream
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W Islip
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White Plains
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City
Wiliamsville
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Williamsville
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City
Woodbury
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City
Asheville
State/Province
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City
Boone
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Burlington
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Charlotte
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Concord
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Durham
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Elizabeth
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City
Fayetteville
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City
Forest City
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City
Goldsboro
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City
Greensboro
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City
Greenville
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City
Hickory
State/Province
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Kinston
State/Province
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City
Raleigh
State/Province
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City
Salisbury
State/Province
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City
Valdese
State/Province
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Wilmington
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Winston-Salem
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Bismarck
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Fargo
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Grand Forks
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Akron
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Ohio
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Barberton
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Bryan
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Canton
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Ohio
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Cincinnati
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Ohio
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City
Cleveland
State/Province
Ohio
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City
Columbus
State/Province
Ohio
Country
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City
Dayton
State/Province
Ohio
Country
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City
Fairfield
State/Province
Ohio
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City
Finley
State/Province
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City
Independence
State/Province
Ohio
Country
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City
Kettering
State/Province
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Mansfield
State/Province
Ohio
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City
Mentor
State/Province
Ohio
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City
Middleburg Heights
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Ohio
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City
Middletown
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Ohio
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City
Sandusky
State/Province
Ohio
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City
Toledo
State/Province
Ohio
Country
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City
Troy
State/Province
Ohio
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City
Warrensville Heights
State/Province
Ohio
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City
Wooster
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Ohio
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Youngstown
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City
Zanesville
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Ohio
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City
Enid
State/Province
Oklahoma
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City
Lawton
State/Province
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City
Oklahoma City
State/Province
Oklahoma
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City
Ponca City
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Stillwater
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Tulsa
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Bend
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Coos Bay
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Corvallis
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Eugene
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Klamath
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Medford
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Portland
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Salem
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Tualatin
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Allentown
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Bryn Mawr
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Butler
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Cellarsville
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United States
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Danville
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Drexel Hill
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Dunmore
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E. Stroudsburg
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Easton
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Ephrata
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Erie
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Franklin
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Greensburg
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Harrisburg
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Hazelton
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Kingston
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Kittanning
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Lancaster
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Langhorne
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Langhorn
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Lemoyne
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Philadelphia
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Phoenixville
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Pittsburgh
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Pottstown
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Pottsville
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Sayre
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Scranton
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St Marys
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State College
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West Reading
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York
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Pawtucket
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Providence
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Warwick
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Westerly
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Charleston
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Columbia
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Florence
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Greenville
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Mt. Pleasant
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Myrtle Beach
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Spartenburg
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Aberdeen
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Rapid City
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Sioux Falls
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Chattanooga
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Collierville
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Jackson
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Johnson City
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Knoxville
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Memphis
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Nashville
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Abilene
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Amarillo
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Arlington
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Austin
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Baytown
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Beaumont
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Bryan
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Corpus Christi
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Dallas
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El Paso
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Fredricksburg
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Ft Worth
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Garland
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Houston
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Irving
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Lewisville
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Lubbock
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McAllen
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Mesquite
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Midland
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New Braunfels
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Paris
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Pasadena
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Plano
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Richmond
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San Antonio
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San Marcos
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Sherman
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Temple
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Tyler
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Victoria
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Waco
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Walla Walla
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Webster
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Ivins
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Ogden
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Salt Lake City
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Bennington
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Vermont
Country
United States
Facility Name
Research Site
City
Rutland
State/Province
Vermont
Country
United States
Facility Name
Research Site
City
Abington
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Chesapeake
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Danville
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Fredericksburg
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Hampton
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Lynchburg
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Newport News
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Portsmouth
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Roanoke
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Williamsburg
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Woodridge
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Auburn
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Bremerton
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Kennewick
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Kirkland
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Mount Vernon
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Olympia
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Renton
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Vancouver
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Clarksburg
State/Province
West Virginia
Country
United States
Facility Name
Research Site
City
Huntington
State/Province
West Virginia
Country
United States
Facility Name
Research Site
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
Research Site
City
Princeton
State/Province
West Virginia
Country
United States
Facility Name
Research Site
City
Wheeling
State/Province
West Virginia
Country
United States
Facility Name
Research Site
City
Appleton
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Eau Claire
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Green Bay
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Janesville
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
La Crosse
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Manitowoc
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Marshfield
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Racine
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Rhinelander
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Sheboygan
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Waukesha
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Wausau
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Cheyenne
State/Province
Wyoming
Country
United States

12. IPD Sharing Statement

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