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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00911508




Registration number
NCT00911508
Ethics application status
Date submitted
28/05/2009
Date registered
29/05/2009
Date last updated
22/02/2018

Titles & IDs
Public title
Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
Scientific title
Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
Secondary ID [1] 0 0
U01HL089709
Secondary ID [2] 0 0
09-004616
Universal Trial Number (UTN)
Trial acronym
CABANA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Arrhythmia 0 0
Atrial Fibrillation 0 0
Arrhythmia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Left atrial ablation
Treatment: Drugs - Rate or Rhythm Control Therapy
Treatment: Devices - Left atrial ablation
Treatment: Drugs - Rate or Rhythm Control Therapy

Active Comparator: Left Atrial Ablation - Pulmonary vein isolation using a circumferential ablative approach in the left atrium. Ablation may be performed using circular mapping catheter-guided ablation, antral isolation using a circular guided approach, or wide area circumferential ablation.

Active Comparator: Rate or Rhythm Control Therapy - Current state-of-the-art drug therapy for atrial fibrillation (rate control or rhythm control). Treating physicians will be encouraged to follow the American College of Cardiology / American Heart Association / European Society of Cardiology Atrial Fibrillation Guidelines with regard to drug therapy for atrial fibrillation. The specific choice of rate control versus rhythm control drug therapy and the specific drugs to be used will ultimately be left to the discretion of the treating physician.

Active Comparator: Left Atrial Ablation - Pulmonary vein isolation using a circumferential ablative approach in the left atrium. Ablation may be performed using circular mapping catheter-guided ablation, antral isolation using a circular guided approach, or wide area circumferential ablation.

Active Comparator: Rate or Rhythm Control Therapy - Current state-of-the-art drug therapy for atrial fibrillation (rate control or rhythm control). Treating physicians will be encouraged to follow the American College of Cardiology / American Heart Association / European Society of Cardiology Atrial Fibrillation Guidelines with regard to drug therapy for atrial fibrillation. The specific choice of rate control versus rhythm control drug therapy and the specific drugs to be used will ultimately be left to the discretion of the treating physician.


Treatment: Devices: Left atrial ablation
St. Jude: Livewire TC™ , Therapy™ Dual / Thermocouple, Safire,Therapy Cool Path
Biosense Webster: NAVI-STAR, NAVI-STAR/NAVI-STAR DS, Celsius Braided/Long Tip, NAVI-STAR™ and Celsius™ ThermoCool, NAVI-STAR® RMT, Celsius® RMT, ThermoCool® SF
Medtronic CryoCath LP: Freezor®/Freezor MAX®, Artic Front®, Cardiac Ablation System
Bard: Stinger
Boston Scientific: Blazer II RF/XP, Blazer RPM, Chilli II Cooled, SteeroCath

Treatment: Drugs: Rate or Rhythm Control Therapy
Rate control: Metoprolol 50-100mg, Atenolol 50-100mg, Propranolol 40-80mg, Acebutolol 200-300mg, Carvedilol 6.25-25mg, Diltiazem 180-240mg, Verapamil 180-240mg, Digoxin 0.125-0.25mg
Rhythm control: Propafenone 450-625mg, Flecainide 200-300mg, Sotalol 240-320mg, Dofetilide 500-1000mcg, Amiodarone 200-400mg, Quinidine 600-900mg, Dronedarone 800mg

Treatment: Devices: Left atrial ablation
St. Jude: Livewire TC™ , Therapy™ Dual / Thermocouple, Safire,Therapy Cool Path
Biosense Webster: NAVI-STAR, NAVI-STAR/NAVI-STAR DS, Celsius Braided/Long Tip, NAVI-STAR™ and Celsius™ ThermoCool, NAVI-STAR® RMT, Celsius® RMT, ThermoCool® SF
Medtronic CryoCath LP: Freezor®/Freezor MAX®, Artic Front®, Cardiac Ablation System
Bard: Stinger
Boston Scientific: Blazer II RF/XP, Blazer RPM, Chilli II Cooled, SteeroCath

Treatment: Drugs: Rate or Rhythm Control Therapy
Rate control: Metoprolol 50-100mg, Atenolol 50-100mg, Propranolol 40-80mg, Acebutolol 200-300mg, Carvedilol 6.25-25mg, Diltiazem 180-240mg, Verapamil 180-240mg, Digoxin 0.125-0.25mg
Rhythm control: Propafenone 450-625mg, Flecainide 200-300mg, Sotalol 240-320mg, Dofetilide 500-1000mcg, Amiodarone 200-400mg, Quinidine 600-900mg, Dronedarone 800mg

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
LA catheter ablation is superior to rate or rhythm control drug therapy for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients warranting therapy for AF.
Timepoint [1] 0 0
From date of enrollment until date of event
Primary outcome [2] 0 0
LA catheter ablation is superior to rate or rhythm control drug therapy for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients warranting therapy for AF.
Timepoint [2] 0 0
From date of enrollment until date of event
Secondary outcome [1] 0 0
LA catheter ablation is superior to rate or rhythm control drug therapy for reducing total mortality
Timepoint [1] 0 0
From date of enrollment until date of death
Secondary outcome [2] 0 0
Total mortality, stroke, or CV hospitalization (for heart failure or acute ischemic events)
Timepoint [2] 0 0
From date of enrollment until date of death, stroke, or CV hospitalization (for heart failure or acute ischemic event)
Secondary outcome [3] 0 0
Cardiovascular death
Timepoint [3] 0 0
From date of enrollment until date of death
Secondary outcome [4] 0 0
Cardiovascular death or disabling stroke
Timepoint [4] 0 0
From date of enrollment until date of event
Secondary outcome [5] 0 0
Arrhythmic death or cardiac arrest
Timepoint [5] 0 0
From date of enrollment until date of event
Secondary outcome [6] 0 0
Heart failure death
Timepoint [6] 0 0
From date of enrollment until date of event
Secondary outcome [7] 0 0
Freedom from recurrent AF
Timepoint [7] 0 0
From date of therapy initiation until date of first AF recurrence following a 90 day wait period
Secondary outcome [8] 0 0
Cardiovascular hospitalization
Timepoint [8] 0 0
From date of enrollment until date of hospitalization
Secondary outcome [9] 0 0
Medical costs, resource utilization, and cost effectiveness
Timepoint [9] 0 0
From date of enrollment through follow-up (average of 5 years)
Secondary outcome [10] 0 0
Quality of Life
Timepoint [10] 0 0
At months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60
Secondary outcome [11] 0 0
Composite adverse events
Timepoint [11] 0 0
From date of enrollment until date of event
Secondary outcome [12] 0 0
Left atrial size, morphology and function and its relationship to morbidity and mortality
Timepoint [12] 0 0
Baseline compared with 3-6 months post therapy initiation
Secondary outcome [13] 0 0
LA catheter ablation is superior to rate or rhythm control drug therapy for reducing total mortality
Timepoint [13] 0 0
From date of enrollment until date of death
Secondary outcome [14] 0 0
Total mortality, stroke, or CV hospitalization (for heart failure or acute ischemic events)
Timepoint [14] 0 0
From date of enrollment until date of death, stroke, or CV hospitalization (for heart failure or acute ischemic event)
Secondary outcome [15] 0 0
Cardiovascular death
Timepoint [15] 0 0
From date of enrollment until date of death
Secondary outcome [16] 0 0
Cardiovascular death or disabling stroke
Timepoint [16] 0 0
From date of enrollment until date of event
Secondary outcome [17] 0 0
Arrhythmic death or cardiac arrest
Timepoint [17] 0 0
From date of enrollment until date of event
Secondary outcome [18] 0 0
Heart failure death
Timepoint [18] 0 0
From date of enrollment until date of event
Secondary outcome [19] 0 0
Freedom from recurrent AF
Timepoint [19] 0 0
From date of therapy initiation until date of first AF recurrence following a 90 day wait period
Secondary outcome [20] 0 0
Cardiovascular hospitalization
Timepoint [20] 0 0
From date of enrollment until date of hospitalization
Secondary outcome [21] 0 0
Medical costs, resource utilization, and cost effectiveness
Timepoint [21] 0 0
From date of enrollment through follow-up (average of 5 years)
Secondary outcome [22] 0 0
Quality of Life
Timepoint [22] 0 0
At months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60
Secondary outcome [23] 0 0
Composite adverse events
Timepoint [23] 0 0
From date of enrollment until date of event
Secondary outcome [24] 0 0
Left atrial size, morphology and function and its relationship to morbidity and mortality
Timepoint [24] 0 0
Baseline compared with 3-6 months post therapy initiation

Eligibility
Key inclusion criteria
- Over the preceding 6 months have:

1. =2 paroxysmal (electrocardiographic documentation of at least 1) AF episodes
lasting =1 hour in duration: (that terminate spontaneously within 7 days or
cardioversion is performed within 48h of AF onset): or

2. electrocardiographic documentation of 1 persistent AF episode: (sustained for =7
days or cardioversion is performed more than 48h after AF onset): or

3. electrocardiographic documentation of 1 longstanding persistent AF episode:
(continuous AF of duration >1 year).

- Warrant active therapy (within the past 3 months) beyond simple ongoing observation

- Be eligible for catheter ablation and =2 sequential rhythm control and/or =2 rate
control drugs.

- Be =65 yrs of age, or <65 yrs with one or more of the following risk factors for
stroke: Hypertension (treated and/or defined as a BP >140/90 mmHg) [90], Diabetes
(treated and/or defined as a fasting glucose =126 mg/dl) [91], Congestive heart
failure (including systolic or diastolic heart failure), Prior stroke, TIA or systemic
emboli, Atherosclerotic vascular disease (previous MI, peripheral arterial disease or
aortic plaque), LA size >5.0 cm (or volume index =40 cc/m2), or EF =35.

- Have the capacity to understand and sign an informed consent form.

- Be =18 years of age.

- NOTE- Subjects <65 yrs of age whose only risk factor is hypertension must have a
second risk factor or LV hypertrophy to qualify.Patients receiving new drug
therapy initiated within the previous 3 months may continue that therapy if
randomized to the drug therapy arm. Patients may have documented atrial flutter
in addition to atrial fibrillation and remain eligible for enrollment.
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Lone AF in the absence of risk factors for stroke in patients <65 years of age

- Patients who in the opinion of the managing clinician should not yet receive any
therapy for AF

- Patients who have failed >2 membrane active anti-arrhythmic drugs at a therapeutic
dose due to inefficacy or side effects (Table 5.2.2)

- An efficacy failure of full dose amiodarone treatment >8 weeks duration at any time

- Reversible causes of AF including thyroid disorders, acute alcohol intoxication,
recent major surgical procedures, or trauma

- Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3
months

- Hypertrophic obstructive cardiomyopathy (outflow track)

- Class IV angina or Class IV CHF (including past or planned heart transplantation)

- Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. VT, VF)

- Heritable arrhythmias or increased risk for torsade de pointes with class I or III
drugs

- Prior LA catheter ablation with the intention of treating AF

- Prior surgical interventions for AF such as the MAZE procedure

- Prior AV nodal ablation

- Patients with other arrhythmias requiring ablative therapy

- Contraindication to appropriate anti-coagulation therapy

- Renal failure requiring dialysis

- Medical conditions limiting expected survival to <1 year

- Women of childbearing potential (unless post-menopausal or surgically sterile)

- Participation in any other clinical mortality trial (Participation in other
non-mortality trials should be reviewed with the clinical trial management center)

- Unable to give informed consent

- NOTE- Prior ablation of the cavo-tricuspid isthmus alone is not an exclusion if
the patient develops subsequent recurrent AF. Planned atrial flutter ablation in
combination with the left atrial ablation is not an exclusion.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
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Maryland
Country [11] 0 0
United States of America
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Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
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United States of America
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Minnesota
Country [14] 0 0
United States of America
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Mississippi
Country [15] 0 0
United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
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United States of America
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Tennessee
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United States of America
State/province [25] 0 0
Texas
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United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
United States of America
State/province [29] 0 0
Wisconsin
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
China
State/province [32] 0 0
Guangdong
Country [33] 0 0
China
State/province [33] 0 0
Jiangsu
Country [34] 0 0
China
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Liaoning
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China
State/province [35] 0 0
Beijing
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Czechia
State/province [36] 0 0
Hlavni Mesto Praha
Country [37] 0 0
Czechia
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Brno
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Czechia
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Prague 2
Country [39] 0 0
Czechia
State/province [39] 0 0
Prague 4
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Germany
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Baden-Wurttemberg
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Germany
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Bayern
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Germany
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Freie-Hansestadt Hamburg
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Germany
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Nordrhein-Westfalen
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Germany
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Saxony
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Germany
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Bad Nauheim
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Germany
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Dresden
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Germany
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Frankfurt
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Germany
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Gottingen
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Germany
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Hamburg
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Germany
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Karlsruhe
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Germany
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Leipzig
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Germany
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Rostock
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Italy
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Lombardia
Country [54] 0 0
Italy
State/province [54] 0 0
Milan
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Italy
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Varese
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Korea, Republic of
State/province [56] 0 0
Seoul
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Russian Federation
State/province [57] 0 0
Novosibirskaya Oblast
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Moscow
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Russian Federation
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Tomsk
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Glasgow
Country [61] 0 0
United Kingdom
State/province [61] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Mayo Clinic
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Abbott Medical Devices
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Biosense Webster, Inc.
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Commercial sector/Industry
Name [5] 0 0
Abbott Medical Devices
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Commercial sector/Industry
Name [6] 0 0
Biosense Webster, Inc.
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial)
CABANA Trial has the overall goal of establishing the appropriate roles for medical and
ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the
hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of
eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy
with either rate control or rhythm control drugs for decreasing the incidence of the
composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest
in patients with untreated or incompletely treated AF.
Trial website
https://clinicaltrials.gov/show/NCT00911508
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Douglas L. Packer, M.D.
Address 0 0
Mayo Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications