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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00291330
Registration number
NCT00291330
Ethics application status
Date submitted
13/02/2006
Date registered
14/02/2006
Date last updated
6/06/2014
Titles & IDs
Public title
Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
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Scientific title
A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.
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Secondary ID [1]
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2005-001999-12
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Secondary ID [2]
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1160.53
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Universal Trial Number (UTN)
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Trial acronym
RE-COVER I
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Thromboembolism
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Condition category
Condition code
Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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0
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - dabigatran etexilate 150 mg
Treatment: Drugs - warfarin (INR 2-3)
Experimental: dabigatran etexilate 150 mg - twice daily
Active Comparator: warfarin (INR 2-3) - prn to maintain INR (2-3)
Treatment: Drugs: dabigatran etexilate 150 mg
twice daily
Treatment: Drugs: warfarin (INR 2-3)
prn to maintain INR (2-3)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE
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Assessment method [1]
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All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
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Timepoint [1]
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For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)
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Secondary outcome [1]
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Number of Participants With Recurrent Symptomatic VTE and All Deaths
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Assessment method [1]
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VTE or any death which occured from randomisation to end of post treatment period.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
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Timepoint [1]
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For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
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Secondary outcome [2]
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Number of Participants With Recurrent Symptomatic DVT
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Assessment method [2]
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Symptomatic DVT which occured from randomisation to end of post treatment period.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
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Timepoint [2]
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For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
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Secondary outcome [3]
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Number of Participants With Recurrent Symptomatic Non-fatal PE
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Assessment method [3]
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Symptomatic non-fatal PE which occured from randomisation to end of post treatment period.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
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Timepoint [3]
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For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
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Secondary outcome [4]
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Number of Participants Who Died Due to VTE
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Assessment method [4]
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VTE - related deaths which occured from randomisation to end of post treatment period.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
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Timepoint [4]
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For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
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Secondary outcome [5]
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Number of Participants Who Died (Any Cause)
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Assessment method [5]
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Any deaths which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
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Timepoint [5]
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For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
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Secondary outcome [6]
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Number of Participants With Bleeding Events
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Assessment method [6]
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Major bleeding events (MBE) were defined as
Fatal bleeding
Symptomatic bleeding in a critical area or organ
Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells
Clinically-relevant bleeding events (CRBE) was defined as
spontaneous skin hematoma >=25 cm²
spontaneous nose bleed >5 min
macroscopic hematuria spontaneous or >24 hours if associated with an intervention
spontaneous rectal bleeding (more than spotting on toilet paper)
gingival bleeding >5 min
leading to hospitalisation and / or requiring surgical treatment
leading to a transfusion of <2 units of whole blood or red cells
any other bleeding event considered clinically relevant by the investigator
Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
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Timepoint [6]
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From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug)
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Secondary outcome [7]
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Number of Participants With Acute Coronary Syndrome (ACS)
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Assessment method [7]
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Any ACS occurring during the conduct of the study (centrally adjudicated as definite).
Counts of patients having a centrally adjudicated definite ACS during intake of active study drug, after stopping active study drug and before or without intake of active study drug, according to treatment group.
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
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Timepoint [7]
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From first intake of study drug to end of study conduct
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Secondary outcome [8]
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Laboratory Analyses
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Assessment method [8]
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Frequency of patients with possible clinically significant abnormalities.
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Timepoint [8]
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From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug)
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Eligibility
Key inclusion criteria
Inclusion criteria
1. Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary
embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is
considered appropriate
2. Male or female, being 18 years of age or older
3. Written informed consent for study participation
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria
1. Overt symptoms of VTE for longer than 2 weeks prior to enrolment
2. PE satisfying at least one of the following criteria: Haemodynamic instability,
embolectomy is indicated or performed, thrombolytic therapy is indicated or performed,
or suspected source of PE is other than the legs
3. Actual or anticipated use of vena cava filter
4. Contraindications to anticoagulant therapy
5. Patients who in the investigators opinion should not be treated with warfarin
6. Allergy to heparins or other alternate approved therapy used for initial treatment,
warfarin or dabigatran, or to one of the excipients included in these medications
7. Patients who in the investigators judgement are perceived as having an excessive risk
of bleeding
8. Known anaemia
9. Need of anticoagulant treatment for disorders other than VTE
10. Recent unstable cardiovascular disease
11. Elevated AST or ALT > 2x ULN
12. Liver disease expected to have any potential impact on survival
13. Patients who have developed transaminase elevations upon exposure to ximelagatran
14. Severe renal impairment
15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a
medically acceptable form of contraception
16. Participation in another clinical trial with an investigational drug during the last
30 days or previous participation in this study
17. Patients considered unsuitable for inclusion by the investigator
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
2564
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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1160.53.61002 Boehringer Ingelheim Investigational Site - Woolloongabba
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Recruitment hospital [2]
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1160.53.61004 Boehringer Ingelheim Investigational Site - Bedford Park
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Recruitment hospital [3]
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1160.53.61003 Boehringer Ingelheim Investigational Site - Box Hill
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Recruitment hospital [4]
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1160.53.61001 Boehringer Ingelheim Investigational Site - Clayton
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Recruitment hospital [5]
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1160.53.61006 The Avenue Cardiovascular Centre - Windsor
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Recruitment hospital [6]
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1160.53.61005 Boehringer Ingelheim Investigational Site - Perth
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Recruitment postcode(s) [1]
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- Woolloongabba
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Recruitment postcode(s) [2]
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- Bedford Park
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Recruitment postcode(s) [3]
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- Box Hill
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Recruitment postcode(s) [4]
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- Clayton
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Recruitment postcode(s) [5]
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- Windsor
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Recruitment postcode(s) [6]
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- Perth
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Recruitment outside Australia
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United States of America
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Alabama
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Maryland
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Michigan
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Minnesota
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New Hampshire
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New York
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North Carolina
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Argentina
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Capital Federal
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Austria
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Graz
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Austria
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Innsbruck
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Nancy
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Vadodara
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Israel
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Petah Tiqwa
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Country [102]
0
0
Israel
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0
Tel Hashomer
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Israel
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Tel-Aviv
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Country [104]
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Israel
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Zerifin
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Country [105]
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Italy
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Bologna
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Country [106]
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Italy
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Padova
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Country [107]
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Italy
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Perugia
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Country [108]
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Italy
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Reggio Emilia
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Country [109]
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Italy
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Vimercate
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Italy
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Vittorio Veneto (tv)
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Country [111]
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Mexico
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Chihuahua
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Mexico
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Culiacan
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Mexico
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San Luis Potosí
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Netherlands
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's Hertogenbosch
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Netherlands
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Amersfoort
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Netherlands
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Amsterdam
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Netherlands
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Eindhoven
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Netherlands
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Maastricht
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Netherlands
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Nieuwegein
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Netherlands
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Rotterdam
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Otahuhu Auckland
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New Zealand
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Takapuna Auckland
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Norway
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Oslo
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Norway
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Rud
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Norway
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Trondheim
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Portugal
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Almada
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Portugal
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Coimbra
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Portugal
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Lisboa
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Russian Federation
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Chelyabinsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Krasnodar
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Country [138]
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Russian Federation
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Pskov
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Country [139]
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Russian Federation
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Rostov-na-Donu
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Country [140]
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Russian Federation
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St. Petersburg
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Country [141]
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Russian Federation
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Ufa
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Country [142]
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Russian Federation
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Yaroslavl
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Country [143]
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Slovakia
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Banska Bystrica
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Slovakia
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Lucenec
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Slovakia
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Nitra
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Country [146]
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Slovakia
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Nove Zamky
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Country [147]
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Slovakia
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State/province [147]
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Zilina
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Country [148]
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South Africa
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State/province [148]
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Centurion
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Country [149]
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South Africa
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Johannesburg
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Country [150]
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South Africa
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Pretoria
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Country [151]
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South Africa
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Randburg
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Country [152]
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South Africa
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Richards Bay
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Country [153]
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South Africa
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Roodepoort
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Country [154]
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Spain
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Badalona (Barcelona)
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Spain
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Barcelona
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Country [156]
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Spain
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Cartagena. Murcia
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Country [157]
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Spain
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Cuenca
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Spain
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Madrid
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Country [159]
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Spain
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Santander
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Country [160]
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Spain
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State/province [160]
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Torrelavega.Santander
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Country [161]
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Spain
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Valencia
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Country [162]
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Sweden
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Göteborg
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Country [163]
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Sweden
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State/province [163]
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Jönköping
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Country [164]
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Sweden
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State/province [164]
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Stockholm
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Country [165]
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Sweden
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Sundsvall
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Country [166]
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Sweden
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Uppsala
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Country [167]
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Turkey
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Ankara
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Country [168]
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Turkey
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Istanbul
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Country [169]
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Turkey
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Izmir
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Country [170]
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Ukraine
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Kiev
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Country [171]
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Ukraine
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Vinnitsa
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Country [172]
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Ukraine
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Zaporozhye
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Country [173]
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United Kingdom
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Aberdeen
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Country [174]
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United Kingdom
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Headington, Oxford
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Country [175]
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United Kingdom
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London
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Country [176]
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this trial is to determine the comparative safety and efficacy of dabigatran
etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to
maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute
symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a
parenteral anticoagulant approved for this indication. This trial aims to demonstrate
non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE.
After achieving non-inferiority, this trial also aims to establish superiority (by means of
hierarchical tests) of dabigatran over warfarin.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00291330
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Public notes
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Contacts
Principal investigator
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Boehringer Ingelheim
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Boehringer Ingelheim
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00291330
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