MONO: Symbicort® Single Inhaler Therapy and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults
A Comparison of the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus As-needed) and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults. A Randomized, Open, Parallel-group, Multicentre 26-weeks Study
1 other identifier
interventional
1,900
3 countries
179
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Sep 2004
Typical duration for phase_4 asthma
179 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 18, 2005
CompletedFirst Posted
Study publicly available on registry
October 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedJanuary 24, 2011
January 1, 2011
2.1 years
October 18, 2005
January 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first severe asthma exacerbation
Secondary Outcomes (6)
Number of asthma exacerbations
Mean use of as-needed medication
Prescribed asthma medication
Asthma Control Questionnaire
Safety: serious adverse events and discontinuations due to adverse events
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of asthma \>= 3 months
- Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1
You may not qualify if:
- Smoking history \> 10 pack-years
- Any significant disease or disorder that may jeopardize the safety of the patient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (179)
Research Site
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Symbicort Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 18, 2005
First Posted
October 20, 2005
Study Start
September 1, 2004
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
January 24, 2011
Record last verified: 2011-01