QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)
NCT ID: NCT01782326
Last Updated: 2016-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3362 participants
INTERVENTIONAL
2013-07-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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QVA149
QVA149 (110/50 μg) once daily
QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI.
Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
Salmeterol/fluticasone (50/500μg) b.i.d
Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
Salmeterol/fluticasone dry inhalation powder delivered via the Accuhaler device.
Interventions
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QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI.
Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
Salmeterol/fluticasone dry inhalation powder delivered via the Accuhaler device.
Eligibility Criteria
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Inclusion Criteria
* Male or female adults aged ≥40 years
* Patients with stable Chronic Obstructive Pulmonary Disease ( COPD) according to the current GOLD strategy (GOLD 2011)
* Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years)
* Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥25 and \< 60% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) \< 0.70 at day -28. (Post refers to 1 hour after sequential inhalation of 84 µg (or equivalent dose) of ipratropium bromide and 400 µg of salbutamol)
* A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics
* Patients taking stable COPD medication (at least 60 days) prior to day 28
* Patients with an mMRC grade of at least 2 at day 28
Exclusion Criteria
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
* Patients with Type I or uncontrolled Type II diabetes
* Patients with a history of long QT syndrome or whose QTc measured at day 28 (Fridericia method) is prolonged (\>450 ms for males and females) and confirmed by a central assessor. These patients should not be re-screened
* Patients who have a clinically significant ECG abnormality prior to randomization. (These patients should not be re-screened)
* Patients who have a clinically significant laboratory abnormality at screening
* Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), arrhythmia (see below for patients with atrial fibrillation), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment
* Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded
* Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at both pre-randomization visits, with a resting ventricular rate \< 100/min. At screening the atrial fibrillation must be confirmed by central reading
* Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: anticholinergic agents, long and short acting beta-2 agonists, sympathomimetic amines, lactose or any of the other excipients of trial medication
* Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
* Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. Benign Prostatic Hyperplasia (BPH) patients who are stable on treatment can be considered
* Patients who have not achieved an acceptable spirometry results at screening in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria)
* Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to screening
* Patients who develop a COPD exacerbation of any severity (mild/moderate/severe) between screening and treatment will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation
* Patients who have had a respiratory tract infection within 4 weeks prior to screening
* Patients who develop a respiratory tract infection between screening and prior to treatment will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection
* Patients requiring long term oxygen therapy prescribed for \>12 hours per day
* Patients with any history of asthma
* Patients with an onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years
* Patients with a blood eosinophil count \> 600/mm3 at screening
* Patients with allergic rhinitis who use a H1 antagonist or intra-nasal corticosteroids intermittently (treatment with a stable dose or regimen is permitted)
* Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension)
* Patients with clinically significant bronchiectasis
* Patients with a diagnosis of α-1 anti-trypsin deficiency
* Patients with active pulmonary tuberculosis, unless confirmed by imaging to be no longer active
* Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation
* Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study. (Maintenance program is permitted.)
* Patients receiving any medications in the classes listed in the protocol
* Patients receiving any COPD related medications in the classes specified in the protocol must undergo the required washout period prior to screening and follow the adjustment to treatment program
* Use of other investigational drugs/devices (approved or unapproved) at the time of enrollment, or within 30 days or 5 half-lives of screening, whichever is longer
* Patients unable to use an electronic patient diary and EXACT pro diary
* Patients unable to use a dry powder inhaler device, Metered Dose Inhaler (MDI) or a pressurized MDI (rescue medication) or comply with the study regimen.
40 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Ciudad de Buenos Aires, Argentina, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Lanús, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Concepción del Uruguay, Entre Ríos Province, Argentina
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Mendoza, Mendoza Province, Argentina
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Mendoza, Mendoza Province, Argentina
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Salta, Salta Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Feldbach, Austria, Austria
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Feldkirch, Austria, Austria
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Graz, Austria, Austria
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Grieskirchen, Austria, Austria
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Linz, Austria, Austria
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Thalheim bei Wels, Austria, Austria
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Wels, Austria, Austria
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Innsbruck, Tyrol, Austria
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Salzburg, , Austria
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Vienna, , Austria
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Gosselies, BEL, Belgium
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Genk, Limburg, Belgium
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Luxembourg, Luxembourg, Belgium
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Aalst, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Erpent, , Belgium
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Ghent, , Belgium
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Gilly, , Belgium
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Hasselt, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Ostend, , Belgium
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Roeselare, , Belgium
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Turnhout, , Belgium
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Wavre, , Belgium
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Rousse, Bulgaria, Bulgaria
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Sofia, Bulgaria, Bulgaria
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Varna, Bulgaria, Bulgaria
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Gabrovo, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Troyan Municipality, , Bulgaria
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Burlington, Ontario, Canada
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Downsview, Ontario, Canada
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Toronto, Ontario, Canada
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Mirabel, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Santiago, Santiago Metropolitan, Chile
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Quillota, , Chile
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Beijing, Beijing Municipality, China
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Haikou, Hainan, China
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Shijiazhuang, Hebei, China
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Nanjing, Jiangsu, China
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Shengyang, Liaoning, China
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Xi’an, Shanxi, China
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Chengdu, Sichuan, China
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Hangzhou, Zhejiang, China
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Beijing, , China
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Chongqing, , China
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Chongqing, , China
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Guangzhou, , China
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Shanghai, , China
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Tianjin, , China
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Bogota, Cundinamarca, Colombia
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Floridablanca, Santander Department, Colombia
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Armenia, , Colombia
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Medellín, , Colombia
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Zagreb, Croatia, Croatia
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Karlovac, , Croatia
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Zagreb, , Croatia
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Cvikov, Czech Republic, Czechia
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Český Krumlov, Czech Republic, Czechia
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Jindrichuv Hradec III, Czech Republic, Czechia
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Ostrava - Hrabuvka, Czech Republic, Czechia
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Pardubice, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Praha 6 - Repy, Czech Republic, Czechia
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Strakonice, Czech Republic, Czechia
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Teplice, Czech Republic, Czechia
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Žatec, Czech Republic, Czechia
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Benešov, , Czechia
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Olomouc, , Czechia
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Aalborg, Denmark, Denmark
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Hellerup, Denmark, Denmark
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Hvidovre, Denmark, Denmark
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Roskilde, Denmark, Denmark
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Silkeborg, Denmark, Denmark
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Sønderborg, Denmark, Denmark
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Aarhus, , Denmark
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Copenhagen NV, , Denmark
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Næstved, , Denmark
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Tartu, Estonia, Estonia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Turku, Finland, Finland
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Helsinki, , Finland
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HUS, , Finland
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Jyväskylä, , Finland
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Kuopio, , Finland
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Pori, , Finland
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Beuvry, France, France
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Angers, , France
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Briis-sous-Forges, , France
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Cournonterral, , France
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Lyon, , France
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Montpellier, , France
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Nantes, , France
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Nantes, , France
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Nîmes, , France
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Pessac, , France
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Reims, , France
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Saint-Génis-des-Fontaines, , France
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Heidelberg, Baden-Wurttemberg, Germany
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Berlin, Germany, Germany
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Berlin, Germany, Germany
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Berlin, Germany, Germany
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Dresden, Germany, Germany
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Leipzig, Germany, Germany
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Marburg, Germany, Germany
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Potsdam, Germany, Germany
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Hanover, Lower Saxony, Germany
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Peine, Lower Saxony, Germany
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Koblenz, North Rhine-Westphalia, Germany
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Cottbus, Saxony, Germany
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Geesthacht, Schleswig-Holstein, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Aschaffenburg, , Germany
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Bad Wörishofen, , Germany
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Bamberg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bielefeld, , Germany
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Bochum, , Germany
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Bonn, , Germany
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Bonn, , Germany
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Cologne, , Germany
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Delitzsch, , Germany
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Duisburg, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Frankfurt, , Germany
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Freudenberg, , Germany
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Gauting, , Germany
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Hagen, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hannover Münden, , Germany
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Kassel, , Germany
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Landsberg, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Lübeck, , Germany
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Minden, , Germany
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München, , Germany
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Neu-Isenburg, , Germany
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Neumünster, , Germany
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Oranienburg, , Germany
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Potsdam, , Germany
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Prien A. Chiemsee, , Germany
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Ratingen, , Germany
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Reinfeld, , Germany
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Rüdersdorf, , Germany
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Schleswig, , Germany
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Schwabach, , Germany
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Solingen, , Germany
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Stade, , Germany
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Teuchern, , Germany
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Ulm, , Germany
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Warendorf, , Germany
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Weinheim, , Germany
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Wissen, , Germany
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Witten, , Germany
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Athens, Greece, Greece
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Serres, Greece, Greece
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Athens, GR, Greece
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Athens, GR, Greece
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Larissa, GR, Greece
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Rethymno, GR, Greece
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Thessaloniki, GR, Greece
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Athens, , Greece
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Heraklion Crete, , Greece
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Thessaloniki, , Greece
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Guatemala City, Departamento de Guatemala, Guatemala
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Guatemala City, Departamento de Guatemala, Guatemala
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Ciudad, Gautemala, Guatemala
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Kowloon, Hong Kong, Hong Kong
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New Territories, Hong Kong, Hong Kong
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Komárom, Hungary, Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Deszk, , Hungary
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Törökbálint, , Hungary
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Reykjavik, , Iceland
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Hyderabad, Andhra Pradesh, India
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Vijayawada, Andhra Pradesh, India
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Visakhapatnam, Andhra Pradesh, India
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Ahmedabad, Gujarat, India
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Ahmedabad, Gujarat, India
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Gurgaon, Haryana, India
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Manipal, Karnataka, India
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Nagpur, Maharashtra, India
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Nagpur, Maharashtra, India
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Ludhiana, Punjab, India
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Chennai, Tamil Nadu, India
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Coimbatore, Tamil Nadu, India
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Coimbatore, Tamil Nadu, India
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Coimbatore, Tamil Nadu, India
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Kolkata, West Bengal, India
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Bangalore, , India
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Ancona, AN, Italy
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Cassano delle Murge, BA, Italy
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Crema, CR, Italy
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Foggia, FG, Italy
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Florence, FI, Italy
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Genova, GE, Italy
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Milan, MI, Italy
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Pavullo nel Frignano, MO, Italy
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Palermo, PA, Italy
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Cittadella, PD, Italy
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Pisa, PI, Italy
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Pordenone, PN, Italy
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Pavia, PV, Italy
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Reggio Emilia, RE, Italy
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Cuasso al Monte, VA, Italy
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Tradate, VA, Italy
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Negrar, VR, Italy
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Napoli, , Italy
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Komaki, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Seto, Aichi-ken, Japan
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Toyoake, Aichi-ken, Japan
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Fukuoka, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Yanagawa, Fukuoka, Japan
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Asahikawa, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Himeji, Hyōgo, Japan
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Sakaidechō, Kagawa-ken, Japan
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Takamatsu, Kagawa-ken, Japan
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Kawasaki, Kanagawa, Japan
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Kochi, Kochi, Japan
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Kōshi, Kumamoto, Japan
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Kyoto, Kyoto, Japan
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Matsusaka, Mie-ken, Japan
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Sendai, Miyagi, Japan
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Kishiwada, Osaka, Japan
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Koshigaya, Saitama, Japan
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Hamamatsu, Shizuoka, Japan
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Hamamatsu, Shizuoka, Japan
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Iwata, Shizuoka, Japan
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Bunkyo-ku, Tokyo, Japan
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Chuo-ku, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Kiyose, Tokyo, Japan
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Meguro City, Tokyo, Japan
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Riga, LV, Latvia
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Daugavpils, , Latvia
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Riga, , Latvia
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Kaunas, LTU, Lithuania
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Kaunas, LT, Lithuania
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Vilnius, LT, Lithuania
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Alytus, , Lithuania
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Klaipėda, , Lithuania
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Vilnius, , Lithuania
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Vilnius, , Lithuania
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Aguascalientes, Aguascalientes, Mexico
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Guadalajara Jalisco, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Puebla City, Puebla, Mexico
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Mexico City, , Mexico
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Almelo, Netherlands, Netherlands
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Enschede, Netherlands, Netherlands
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Harderwijk, Netherlands, Netherlands
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Zutphen, Netherlands, Netherlands
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Assen, , Netherlands
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Breda, , Netherlands
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Eindhoven, , Netherlands
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Geldrop, , Netherlands
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Groningen, , Netherlands
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Follebu, , Norway
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Hønefoss, , Norway
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Kløfta, , Norway
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Kongsvinger, , Norway
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Skedsmokorset, , Norway
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Stavanger, , Norway
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Svelvik, , Norway
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Trondheim, , Norway
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Lipa City, Batangas, Philippines
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Bulacan, Philippines, Philippines
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Quezon City, , Philippines
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Bialystok, , Poland
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Bialystok, , Poland
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Lodz, , Poland
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Piła, , Poland
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Poznan, , Poland
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Sopot, , Poland
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Wroclaw, , Poland
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Lisbon, Lisbon District, Portugal
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Almada, Portugal, Portugal
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Barcelos, Portugal, Portugal
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Braga, Portugal, Portugal
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Coimbra, Portugal, Portugal
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Lisbon, Portugal, Portugal
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Porto, Portugal, Portugal
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Torres Vedras, Portugal, Portugal
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Vila Franca de Xira, Portugal, Portugal
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Vila Nova de Gaia, Portugal, Portugal
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Viseu, Portugal, Portugal
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Bucharest, District 1, Romania
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Bucharest, District 3, Romania
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Craiova, Dolj, Romania
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Iași, Jud. Iasi, Romania
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Brasov, Romania, Romania
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Bucharest, Romania, Romania
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Deva, Romania, Romania
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Iași, Romania, Romania
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Oradea, Romania, Romania
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Târgu Mureş, Romania, Romania
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Timișoara, Timiș County, Romania
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Arad, , Romania
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Arad, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Deva, , Romania
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Barnaul, , Russia
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Chelyabinsk, , Russia
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Kazan', , Russia
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N.Novgorod, , Russia
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Rostov-on-Don, , Russia
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Ryazan, , Russia
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Saratov, , Russia
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Tver', , Russia
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Ufa, , Russia
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Yaroslavl, , Russia
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Belgrade, Serbia, Serbia
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Belgrade, Serbia, Serbia
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Knez-Selo, , Serbia
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Kragujevac, , Serbia
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Bardejov, Slovak Republic, Slovakia
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Bojnice, Slovak Republic, Slovakia
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Humenné, Slovak Republic, Slovakia
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Košice, Slovak Republic, Slovakia
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Liptovský Hrádok, Slovak Republic, Slovakia
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Partizánske, Slovak Republic, Slovakia
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Bratislava, Slovakia, Slovakia
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Košice, Slovakia, Slovakia
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Lučenec, Slovakia, Slovakia
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Martin, Slovakia, Slovakia
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Považská Bystrica, Slovakia, Slovakia
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Námestovo, Slovensko, Slovakia
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Košice, , Slovakia
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Nové Zámky, , Slovakia
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Poprad, , Slovakia
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Spisská Nová Ves, , Slovakia
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Berea, Durban, South Africa
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Sandton, Gauteng, South Africa
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Pretoria, South Africa, South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Gatesville, , South Africa
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Port Elizabeth, , South Africa
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Pretoria, , South Africa
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Bucheon-si, Gyeonggi-do, South Korea
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Jeonju, Jeollabuk-do, South Korea
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, Seoul, South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Córdoba, Andalusia, Spain
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Málaga, Andalusia, Spain
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Sanlúcar de Barrameda, Andalusia, Spain
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Barcelona, Barcelona, Spain
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Torrelavega, Cantabria, Spain
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Burgos, Castille and León, Spain
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Ponferrada, Castille and León, Spain
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Valladolid, Castille and León, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Salt, Catalonia, Spain
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Mérida, Extremadura, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Pozuelo de Alarcón, Madrid, Spain
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Cartagena, Murcia, Spain
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Oviedo, Principality of Asturias, Spain
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Alicante, Valencia, Spain
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Alzira, Valencia, Spain
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Valencia, Valencia, Spain
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Barakaldo, Vizcaya, Spain
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Borås, , Sweden
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Luleå, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Trollhättan, , Sweden
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Uddevalla, , Sweden
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Taichung, Taiwan, Taiwan
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Taipei County, Taiwan, Taiwan
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Tainan City, Taiwan ROC, Taiwan
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Chiayi County, , Taiwan
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Niaosong Township, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Khon Kaen, , Thailand
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Songkhla, , Thailand
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Ankara, Turkey, Turkey (Türkiye)
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Ankara, Turkey, Turkey (Türkiye)
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Izmir, Turkey, Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Kinikli / Denizli, , Turkey (Türkiye)
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Manisa, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Huntingdon, Cambridgeshire, United Kingdom
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Stockton, Cleveland, United Kingdom
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Midsomer Norton, Radstock, United Kingdom
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Axbridge, Somerset, United Kingdom
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Taunton, Somerset, United Kingdom
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South Shields, Tyne and Wear, United Kingdom
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Cambridge, United KIngdom, United Kingdom
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Crawley, West Sussex, United Kingdom
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Bradford, West Yorkshire, United Kingdom
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Birmingham, , United Kingdom
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Chester, , United Kingdom
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Darlington, , United Kingdom
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Lancashire, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Southampton, , United Kingdom
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Tyne & Wear, , United Kingdom
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Wiltshire, , United Kingdom
Countries
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References
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Mathioudakis AG, Bate S, Sivapalan P, Jensen JS, Singh D, Vestbo J. Rethinking Blood Eosinophils for Assessing Inhaled Corticosteroids Response in COPD: A Post Hoc Analysis From the FLAME Trial. Chest. 2024 Nov;166(5):987-997. doi: 10.1016/j.chest.2024.06.3790. Epub 2024 Jul 9.
Mackay AJ, Kostikas K, Roche N, Frent SM, Olsson P, Pfister P, Gupta P, Patalano F, Banerji D, Wedzicha JA. Impact of baseline symptoms and health status on COPD exacerbations in the FLAME study. Respir Res. 2020 Apr 22;21(1):93. doi: 10.1186/s12931-020-01354-8.
Wedzicha JA, Singh D, Tsiligianni I, Jenkins C, Fucile S, Fogel R, Shen S, Goyal P, Mezzi K, Kostikas K. Treatment response to indacaterol/glycopyrronium versus salmeterol/fluticasone in exacerbating COPD patients by gender: a post-hoc analysis in the FLAME study. Respir Res. 2019 Jan 8;20(1):4. doi: 10.1186/s12931-019-0972-7.
Frent SM, Chapman KR, Larbig M, Mackay A, Fogel R, Gutzwiller FS, Shen S, Patalano F, Banerji D, Kostikas K, Wedzicha JA. Capturing Exacerbations of Chronic Obstructive Pulmonary Disease with EXACT. A Subanalysis of FLAME. Am J Respir Crit Care Med. 2019 Jan 1;199(1):43-51. doi: 10.1164/rccm.201801-0038OC.
Anzueto AR, Kostikas K, Mezzi K, Shen S, Larbig M, Patalano F, Fogel R, Banerji D, Wedzicha JA. Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study. Respir Res. 2018 Jun 20;19(1):121. doi: 10.1186/s12931-018-0830-z.
Roche N, Chapman KR, Vogelmeier CF, Herth FJF, Thach C, Fogel R, Olsson P, Patalano F, Banerji D, Wedzicha JA. Blood Eosinophils and Response to Maintenance Chronic Obstructive Pulmonary Disease Treatment. Data from the FLAME Trial. Am J Respir Crit Care Med. 2017 May 1;195(9):1189-1197. doi: 10.1164/rccm.201701-0193OC.
Wedzicha JA, Banerji D, Chapman KR, Vestbo J, Roche N, Ayers RT, Thach C, Fogel R, Patalano F, Vogelmeier CF; FLAME Investigators. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016 Jun 9;374(23):2222-34. doi: 10.1056/NEJMoa1516385. Epub 2016 May 15.
Other Identifiers
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CQVA149A2318
Identifier Type: -
Identifier Source: org_study_id
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