Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

NCT ID: NCT01443845

Last Updated: 2017-04-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-01-31

Brief Summary

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To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.

Detailed Description

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Conditions

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COPD COPD Exacerbation Lung Diseases Respiratory Disorders Pulmonary Disease Chronic Obstructive Lung Diseases Chronic Obstructive Airway Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Roflumilast

Group Type EXPERIMENTAL

Roflumilast

Intervention Type DRUG

Roflumilast 500 µg, oral administration, once per day

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose-matched placebo, oral administration, once per day.

Interventions

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Roflumilast

Roflumilast 500 µg, oral administration, once per day

Intervention Type DRUG

Placebo

Dose-matched placebo, oral administration, once per day.

Intervention Type DRUG

Other Intervention Names

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Daliresp

Eligibility Criteria

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Inclusion Criteria

* 1\. Male or female patients at least 40 years of age
* 2\. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted)
* 3\. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) \< 70% at Screening (Visit 1)
* 4\. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)
* 5\. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)
* 6\. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
* 7\. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years

Exclusion Criteria

* 1\. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable)
* 2\. Known alpha-1-antitrypsin deficiency
* 3\. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.)
* 4\. Body mass index (BMI) ≥ 45 kg/m2
* 5\. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Forest Investigative Site 081

Anniston, Alabama, United States

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Forest Investigative Site 065

Athens, Alabama, United States

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Forest Investigative Site 131

Florence, Alabama, United States

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Mobile, Alabama, United States

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Mesa, Arizona, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Fort Smith, Arkansas, United States

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Little Rock, Arkansas, United States

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Bellflower, California, United States

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Fresno, California, United States

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Fresno, California, United States

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Fullerton, California, United States

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Garden Grove, California, United States

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Lakewood, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Northridge, California, United States

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Palo Alto, California, United States

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Pismo Beach, California, United States

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Riverside, California, United States

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Roseville, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Jose, California, United States

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Forest Investigative Site 209

Torrance, California, United States

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Stamford, Connecticut, United States

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Waterbury, Connecticut, United States

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Newark, Delaware, United States

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Brandon, Florida, United States

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Brandon, Florida, United States

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Brandon, Florida, United States

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Chiefland, Florida, United States

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Clearwater, Florida, United States

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Clearwater, Florida, United States

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Coral Gables, Florida, United States

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DeFuniak Springs, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Walton Beach, Florida, United States

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Gainesville, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Kissimmee, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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Orlando, Florida, United States

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Ormond Beach, Florida, United States

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Pensacola, Florida, United States

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Ponte Vedra, Florida, United States

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Port Orange, Florida, United States

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Saint Cloud, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Winter Park, Florida, United States

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Canton, Georgia, United States

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Dawsonville, Georgia, United States

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Duluth, Georgia, United States

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Gainesville, Georgia, United States

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Lawrenceville, Georgia, United States

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Woodstock, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Eagle, Idaho, United States

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Bolingbrook, Illinois, United States

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Downers Grove, Illinois, United States

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Elk Grove Village, Illinois, United States

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Oak Lawn, Illinois, United States

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Peoria, Illinois, United States

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Springfield, Illinois, United States

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Elwood, Indiana, United States

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Lafayette, Indiana, United States

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Michigan City, Indiana, United States

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Muncie, Indiana, United States

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Council Bluffs, Iowa, United States

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Iowa City, Iowa, United States

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Olathe, Kansas, United States

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Wichita, Kansas, United States

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Bowling Green, Kentucky, United States

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Crescent Springs, Kentucky, United States

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Hazard, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Owensboro, Kentucky, United States

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Lafayette, Louisiana, United States

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Opelousas, Louisiana, United States

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Sunset, Louisiana, United States

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Lewiston, Maine, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Towson, Maryland, United States

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Fall River, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Pittsfield, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Kalamazoo, Michigan, United States

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Livonia, Michigan, United States

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Saint Joseph, Michigan, United States

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Edina, Minnesota, United States

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Fridley, Minnesota, United States

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Rochester, Minnesota, United States

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Chesterfield, Missouri, United States

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Saint Charles, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Butte, Montana, United States

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Missoula, Montana, United States

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Bellevue, Nebraska, United States

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Fremont, Nebraska, United States

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Fremont, Nebraska, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Henderson, Nevada, United States

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Cherry Hill, New Jersey, United States

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Clifton, New Jersey, United States

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Hackensack, New Jersey, United States

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Summit, New Jersey, United States

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Brooklyn, New York, United States

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Great Neck, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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West Seneca, New York, United States

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Asheville, North Carolina, United States

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Burlington, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Elizabeth City, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Forest Investigative Site 280

Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Marion, Ohio, United States

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Marion, Ohio, United States

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Toledo, Ohio, United States

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Zanesville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Beaver, Pennsylvania, United States

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Downingtown, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Tipton, Pennsylvania, United States

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Uniontown, Pennsylvania, United States

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Johnston, Rhode Island, United States

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Lincoln, Rhode Island, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Easley, South Carolina, United States

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Fort Mill, South Carolina, United States

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Gaffney, South Carolina, United States

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Greenville, South Carolina, United States

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Pelzer, South Carolina, United States

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Rock Hill, South Carolina, United States

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Spartanburg, South Carolina, United States

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Union, South Carolina, United States

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Rapid City, South Dakota, United States

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Bristol, Tennessee, United States

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Fayetteville, Tennessee, United States

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Shelbyville, Tennessee, United States

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Arlington, Texas, United States

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Boerne, Texas, United States

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Corsicana, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Huntsville, Texas, United States

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Longview, Texas, United States

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Tyler, Texas, United States

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Colchester, Vermont, United States

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Abingdon, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Charleston, West Virginia, United States

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Morgantown, West Virginia, United States

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West Allis, Wisconsin, United States

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Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Florida, Buenos Aires, Argentina

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La Plata, Buenos Aires, Argentina

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Lanús Este, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Paraná, Entre Ríos Province, Argentina

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Mendoza, Mendoza Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Derqui Pilar - Buenos Aires, , Argentina

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La Plata, , Argentina

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Mendoza, , Argentina

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San Juan Bautista, , Argentina

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San Miguel de Tucumán, , Argentina

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Santa Fe, , Argentina

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Calgary, Alberta, Canada

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North Vancouver, British Columbia, Canada

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Burlington, Ontario, Canada

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Montreal, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Talcahuano, , Chile

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Bogotá, , Colombia

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Bogotá, , Colombia

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Chieti, , Italy

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Roma, , Italy

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Batu Caves, , Malaysia

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Kuala Lumpur, , Malaysia

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Kuala Lumpur, , Malaysia

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Kuantan, , Malaysia

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Monterrey, Nuevo León, Mexico

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Mérida, Yucatán, Mexico

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Guadalajara, , Mexico

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Monterrey, , Mexico

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Bellavista, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Pueblo Libre, , Peru

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Cavite, , Philippines

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Iloilo City, , Philippines

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Iloilo City, , Philippines

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Manila, , Philippines

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Pasig, , Philippines

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Quezon City, , Philippines

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Quezon City, , Philippines

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Quezon City, , Philippines

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Quezon City, , Philippines

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Brasov, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Iași, , Romania

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Iași, , Romania

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Barnaul, , Russia

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Kazan', , Russia

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Kemerovo, , Russia

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Krasnodar, , Russia

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Krasnoyarsk, , Russia

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Moscow, , Russia

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Novosibirsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Tomsk, , Russia

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Yaroslavl, , Russia

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Knez-Selo, Nišava District, Serbia

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Belgrade, , Serbia

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Belgrade, , Serbia

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Belgrade, , Serbia

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Belgrade, , Serbia

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Kamenitz, , Serbia

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Kragujevac, , Serbia

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Cadiz, , Spain

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Loja, , Spain

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Salt, , Spain

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Kaohsiung Hsien, , Taiwan

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Puzih City, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Hat Yai, Changwat Songkhla, Thailand

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Bangkok, , Thailand

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Bangkok, , Thailand

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Muang, , Thailand

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Cherkasy, , Ukraine

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Donetsk, , Ukraine

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Forest Investigative Site 690

Ivano-Frankivsk, , Ukraine

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Forest Investigative Site 697

Kharkiv, , Ukraine

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Forest Investigative Site 693

Kharkiv, , Ukraine

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Forest Investigative Site 682

Kharkiv, , Ukraine

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Forest Investigative Site 709

Kremenchuk, , Ukraine

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Forest Investigative Site 698

Kyiv, , Ukraine

Site Status

Forest Investigative Site 683

Kyiv, , Ukraine

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Forest Investigative Site 684

Kyiv, , Ukraine

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Forest Investigative Site 687

Kyiv, , Ukraine

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Forest Investigative Site 685

Kyiv, , Ukraine

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Forest Investigative Site 681

Lviv, , Ukraine

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Forest Investigative Site 708

Mykolayiv, , Ukraine

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Forest Investigative Site 706

Poltava, , Ukraine

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Forest Investigative Site 695

Sumy, , Ukraine

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Forest Investigative Site 707

Vinnitsa, , Ukraine

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Forest Investigative Site 688

Zaporizhzhia, , Ukraine

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Forest Investigative Site 696

Zaporizhzhya, , Ukraine

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Forest Investigative Site 694

Zaporizhzhya, , Ukraine

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Forest Investigative Site 705

Zaporizhzhya, , Ukraine

Site Status

Countries

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United States Argentina Canada Chile Colombia Italy Malaysia Mexico Peru Philippines Romania Russia Serbia Spain Taiwan Thailand Ukraine

References

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Martinez FJ, Rabe KF, Calverley PMA, Fabbri LM, Sethi S, Pizzichini E, McIvor A, Anzueto A, Alagappan VKT, Siddiqui S, Reisner C, Zetterstrand S, Roman J, Purkayastha D, Bagul N, Rennard SI. Determinants of Response to Roflumilast in Severe Chronic Obstructive Pulmonary Disease. Pooled Analysis of Two Randomized Trials. Am J Respir Crit Care Med. 2018 Nov 15;198(10):1268-1278. doi: 10.1164/rccm.201712-2493OC.

Reference Type DERIVED
PMID: 29763572 (View on PubMed)

Karpefors M, Weatherall J. The Tendril Plot-a novel visual summary of the incidence, significance and temporal aspects of adverse events in clinical trials. J Am Med Inform Assoc. 2018 Aug 1;25(8):1069-1073. doi: 10.1093/jamia/ocy016.

Reference Type DERIVED
PMID: 29579254 (View on PubMed)

Martinez FJ, Rabe KF, Sethi S, Pizzichini E, McIvor A, Anzueto A, Alagappan VK, Siddiqui S, Rekeda L, Miller CJ, Zetterstrand S, Reisner C, Rennard SI. Effect of Roflumilast and Inhaled Corticosteroid/Long-Acting beta2-Agonist on Chronic Obstructive Pulmonary Disease Exacerbations (RE(2)SPOND). A Randomized Clinical Trial. Am J Respir Crit Care Med. 2016 Sep 1;194(5):559-67. doi: 10.1164/rccm.201607-1349OC.

Reference Type DERIVED
PMID: 27585384 (View on PubMed)

Related Links

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Other Identifiers

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ROF-MD-07

Identifier Type: -

Identifier Source: org_study_id

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