MONO: Symbicort® Single Inhaler Therapy and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults

NCT ID: NCT00242411

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-10-31

Brief Summary

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The purpose of the study is to compare the efficacy of a flexible dose of Symbicort (budesonide/formoterol) with conventional stepwise best standard treatment in patients with persistent asthma.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Budesonide/Formoterol Turbuhaler

Intervention Type DRUG

Conventional Best Asthma Therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of asthma \>= 3 months
* Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1

Exclusion Criteria

* Smoking history \> 10 pack-years
* Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
* Any significant disease or disorder that may jeopardize the safety of the patient.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Symbicort Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Aabenraa, , Denmark

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Aalborg, , Denmark

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Albertslund, , Denmark

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Allingåbro, , Denmark

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Ålbæk, , Denmark

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Ålestrup, , Denmark

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Århus C, , Denmark

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Bagsværd, , Denmark

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Ballerup Municipality, , Denmark

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Billund, , Denmark

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Birkerød, , Denmark

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Brønderslev, , Denmark

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Brønshøj, , Denmark

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Ejby, , Denmark

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Fåborg, , Denmark

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Fredericia, , Denmark

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Frederiksberg, , Denmark

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Frederiksberg C, , Denmark

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Frederikshavn, , Denmark

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Frederikssund, , Denmark

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Glesborg, , Denmark

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Glumsø, , Denmark

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Greve, , Denmark

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Hårlev, , Denmark

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Hellerup, , Denmark

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Helsinge, , Denmark

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Herning, , Denmark

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Hillerød, , Denmark

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Holbæk, , Denmark

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Hornbæk, , Denmark

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Horsens, , Denmark

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Humlebæk, , Denmark

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Hvidovre, , Denmark

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Ikast, , Denmark

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Jægerspris, , Denmark

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Karlslunde, , Denmark

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Kåstrup, , Denmark

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Kjellerup, , Denmark

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Klarup, , Denmark

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Kolding, , Denmark

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Kolind, , Denmark

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Korsør, , Denmark

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Kværndrup, , Denmark

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København K, , Denmark

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København S, , Denmark

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København Ø, , Denmark

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Lynge, , Denmark

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Lystrup, , Denmark

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Nakskov, , Denmark

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Nibe, , Denmark

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Nyborg, , Denmark

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Nykøbing Falster, , Denmark

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Nærum, , Denmark

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Næstved, , Denmark

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Nørre Alslev, , Denmark

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Nørresundby, , Denmark

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Odense C, , Denmark

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Odense NV, , Denmark

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Oksbøl, , Denmark

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Randers, , Denmark

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Redsted, , Denmark

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Ringsted, , Denmark

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Risskov, , Denmark

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Roskilde, , Denmark

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Rudkøbing, , Denmark

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Rungsted Kyst, , Denmark

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Rødovre Municipality, , Denmark

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Saltum, , Denmark

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Skibby, , Denmark

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Slagelse, , Denmark

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Stensved, , Denmark

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Struer Municipality, , Denmark

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Sulsted, , Denmark

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Svendborg, , Denmark

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Sæby, , Denmark

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Sønderborg, , Denmark

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Søndersø, , Denmark

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Tåstrup, , Denmark

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Thorsø, , Denmark

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Tølløse, , Denmark

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Tønder, , Denmark

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Varde, , Denmark

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Viborg, , Denmark

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Viby J, , Denmark

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Vojens, , Denmark

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Ølstykke, , Denmark

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Anjalankoski, , Finland

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Espoo, , Finland

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Hammaslahti, , Finland

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Harjavalta, , Finland

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Heinola, , Finland

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Helsingin Kaup, , Finland

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Helsinki, , Finland

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Jakobstad, , Finland

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Joensuu, , Finland

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Joutseno, , Finland

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Jyväskylä, , Finland

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Kajaani, , Finland

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Kinkomaa, , Finland

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Kotka, , Finland

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Kouvola, , Finland

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Kuusamo, , Finland

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Lahti, , Finland

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Lappeenranta, , Finland

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Lapua, , Finland

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Lieto, , Finland

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Lohja, , Finland

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Mäntsälä, , Finland

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Mikkeli, , Finland

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Muhos, , Finland

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Nokia, , Finland

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Oulu, , Finland

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Parkano, , Finland

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Pattijoki, , Finland

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Polvijärvi, , Finland

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Pori, , Finland

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Porvoo, , Finland

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Ristiina, , Finland

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Rovaniemi, , Finland

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Savonlinna, , Finland

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Tampere, , Finland

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Tornio, , Finland

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Turku, , Finland

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Vantaa, , Finland

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Varkaus, , Finland

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Vimpeli, , Finland

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Ylitornio, , Finland

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Ylöjärvi, , Finland

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Aksdal, , Norway

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Arendal, , Norway

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Asker, , Norway

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Årnes, , Norway

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Bergen, , Norway

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Bodø, , Norway

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Drammen, , Norway

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Fevik, , Norway

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Fjerdingby, , Norway

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Flatåsen, , Norway

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Fredrikstad, , Norway

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Fyllingsdalen, , Norway

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Hafrsfjord, , Norway

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Harstad, , Norway

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Haugesund, , Norway

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Hosle, , Norway

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Høvik, , Norway

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Karmsund, , Norway

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Kristiansand, , Norway

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Lena, , Norway

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Lier, , Norway

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Lierskogen, , Norway

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Lillestrøm, , Norway

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Lysaker, , Norway

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Lørenskog, , Norway

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Løvenstad, , Norway

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Molde, , Norway

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Nesbru, , Norway

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Nesttun, , Norway

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Oslo, , Norway

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Paradis, , Norway

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Rådal, , Norway

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Rykkin, , Norway

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Røa, , Norway

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Sandvika, , Norway

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Skedsmokorset, , Norway

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Ski, , Norway

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Skien, , Norway

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Slependen, , Norway

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Spikkestad, , Norway

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Steinkjer, , Norway

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Straume, , Norway

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Strømmen, , Norway

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Svelvik, , Norway

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Søgne, , Norway

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Sørumsand, , Norway

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Tolvsrød, , Norway

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Trollåsen, , Norway

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Tromsø, , Norway

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Trondheim, , Norway

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Ulset, , Norway

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Countries

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Denmark Finland Norway

Other Identifiers

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D5890L00008

Identifier Type: -

Identifier Source: org_study_id

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