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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06077864




Registration number
NCT06077864
Ethics application status
Date submitted
27/09/2023
Date registered
11/10/2023

Titles & IDs
Public title
A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
Scientific title
A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease (CVD) or Chronic Kidney Disease, and/or at Least Two Weight-related Complications or Risk Factors for CVD
Secondary ID [1] 0 0
2022-502442-27-00
Secondary ID [2] 0 0
1404-0040
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - survodutide
Treatment: Drugs - Placebo

Experimental: survodutide 3.6 mg -

Experimental: survodutide 6.0 mg -

Placebo comparator: Placebo -


Treatment: Drugs: survodutide
once weekly subcutaneous injection

Treatment: Drugs: Placebo
once weekly subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority)
Timepoint [1] 0 0
up to Week 114
Secondary outcome [1] 0 0
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3-point major adverse cardiac event (3P-MACE)) (to demonstrate non-inferiority)
Timepoint [1] 0 0
up to Week 114
Secondary outcome [2] 0 0
Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72
Timepoint [2] 0 0
Baseline and at Week 72
Secondary outcome [3] 0 0
Absolute change in waist circumference (cm) from baseline to Week 72
Timepoint [3] 0 0
Baseline and at Week 72
Secondary outcome [4] 0 0
Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline
Timepoint [4] 0 0
At Baseline and at Week 72
Secondary outcome [5] 0 0
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate superiority)
Timepoint [5] 0 0
up to Week 114
Secondary outcome [6] 0 0
Percentage change in body weight from baseline to Week 72
Timepoint [6] 0 0
Baseline and at Week 72
Secondary outcome [7] 0 0
Absolute change in diastolic blood pressure (DBP) (mmHg) from baseline to Week 72
Timepoint [7] 0 0
Baseline and at Week 72
Secondary outcome [8] 0 0
Absolute change in aspartate aminotransferase (AST) (U/L) from baseline to Week 72
Timepoint [8] 0 0
Baseline and at Week 72
Secondary outcome [9] 0 0
Absolute change in alanine aminotransferase (ALT) (U/L) from baseline to Week 72
Timepoint [9] 0 0
Baseline and at Week 72
Secondary outcome [10] 0 0
Absolute change in glycosylated haemoglobin A1c (HbA1c) (mmol/mol) from baseline to Week 72 in trial participants with type 2 diabetes mellitus (T2DM)
Timepoint [10] 0 0
Baseline and at Week 72
Secondary outcome [11] 0 0
Absolute change in HbA1c (%) from baseline to Week 72 in trial participants with T2DM
Timepoint [11] 0 0
Baseline and at Week 72
Secondary outcome [12] 0 0
Time to onset of T2DM in trial participants without T2DM at baseline
Timepoint [12] 0 0
up to Week 114
Secondary outcome [13] 0 0
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or ischaemia related coronary revascularisation (4-point major adverse cardiac event (4P-MACE))
Timepoint [13] 0 0
up to Week 114
Secondary outcome [14] 0 0
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or HFE (3P-MACE+ HFE)
Timepoint [14] 0 0
up to Week 114
Secondary outcome [15] 0 0
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3P-MACE)
Timepoint [15] 0 0
up to Week 114
Secondary outcome [16] 0 0
Time to first occurrence of adjudicated CV death or adjudicated HFE
Timepoint [16] 0 0
up to Week 114
Secondary outcome [17] 0 0
Time to first occurrence of adjudicated CV death or adjudicated HHF
Timepoint [17] 0 0
up to Week 114
Secondary outcome [18] 0 0
Time to first occurrence of adjudicated HFE
Timepoint [18] 0 0
up to Week 114
Secondary outcome [19] 0 0
Time to adjudicated CV death
Timepoint [19] 0 0
up to Week 114
Secondary outcome [20] 0 0
Time to all-cause mortality
Timepoint [20] 0 0
up to Week 114
Secondary outcome [21] 0 0
Time to first occurrence of adjudicated non-fatal MI
Timepoint [21] 0 0
up to Week 114
Secondary outcome [22] 0 0
Time to first occurrence of adjudicated non-fatal stroke
Timepoint [22] 0 0
up to Week 114
Secondary outcome [23] 0 0
Time to first occurrence of adjudicated ischaemia related coronary revascularisation
Timepoint [23] 0 0
up to Week 114
Secondary outcome [24] 0 0
Achievement of body weight reduction =5% from baseline to Week 72
Timepoint [24] 0 0
Baseline and at Week 72
Secondary outcome [25] 0 0
Achievement of body weight reduction =10% from baseline to Week 72
Timepoint [25] 0 0
Baseline and at Week 72
Secondary outcome [26] 0 0
Achievement of body weight reduction =15% from baseline to Week 72
Timepoint [26] 0 0
Baseline and at Week 72
Secondary outcome [27] 0 0
A composite of death, number of adjudicated HFEs, time to first adjudicated HFE and change from baseline in KCCQ-TSS at 72 weeks assessed by the win ratio in trial participants with HF at baseline
Timepoint [27] 0 0
At baseline and at 72 Weeks

Eligibility
Key inclusion criteria
1. Male or female, age =18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years.
2. Body mass index (BMI) =27 kg/m2 at screening with established cardiovascular disease (CVD) and/or at least 2 weight-related complications or risk factors for CVD OR BMI =30 kg/m2 at screening with established CVD or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD.

Further inclusion criteria apply.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening.
2. Type 1 diabetes.
3. Less than 3 months between the last dose of GLP-1R agonists and GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations and screening.
4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).

Further exclusion criteria apply.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/04/2026
Actual
Sample size
Target
4935
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Boden Initiative - Camperdown
Recruitment hospital [2] 0 0
Novatrials - Kotara
Recruitment hospital [3] 0 0
Royal North Shore Hospital-St Leonards-66471 - St Leonards
Recruitment hospital [4] 0 0
AusTrials - Taringa - Taringa
Recruitment hospital [5] 0 0
AusTrials - Wellers Hill
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Repatriation General Hospital - Daw Park
Recruitment hospital [8] 0 0
Advara Heart Care-Leabrook-69072 - Leabrook
Recruitment hospital [9] 0 0
Victorian Heart Hospital - Clayton
Recruitment hospital [10] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [11] 0 0
Advara Heart Care-Joondalup-69073 - Joondalup
Recruitment postcode(s) [1] 0 0
2006 - Camperdown
Recruitment postcode(s) [2] 0 0
2289 - Kotara
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
4068 - Taringa
Recruitment postcode(s) [5] 0 0
4121 - Wellers Hill
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5041 - Daw Park
Recruitment postcode(s) [8] 0 0
5068 - Leabrook
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3050 - Parkville
Recruitment postcode(s) [11] 0 0
6027 - Joondalup
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
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Illinois
Country [10] 0 0
United States of America
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Indiana
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United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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Minnesota
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United States of America
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Mississippi
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United States of America
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Missouri
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United States of America
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Montana
Country [22] 0 0
United States of America
State/province [22] 0 0
Nebraska
Country [23] 0 0
United States of America
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Nevada
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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United States of America
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Argentina
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Caba
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autonoma de Bs As
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Cordoba
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Argentina
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Mar del Plata
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Argentina
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Parque Velez Sarfield
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Villa Luro
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Austria
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Graz
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Innsbruck
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Linz
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Stockerau
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Edegem
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Fortaleza
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São José dos Campos
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São Paulo
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Bulgaria
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Byala
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Bulgaria
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Dobrich
Country [69] 0 0
Bulgaria
State/province [69] 0 0
Dupnitsa
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Bulgaria
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Plovdiv
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Bulgaria
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Sliven
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Bulgaria
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Sofia
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Bulgaria
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Yambol
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Canada
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Alberta
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Canada
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British Columbia
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Canada
State/province [76] 0 0
Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Changzhou
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China
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Chongqing
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China
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Hangzhou
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China
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Harbin
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China
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Hengyang
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China
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Huai'an
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China
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Huzhou
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China
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Jinan
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China
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Lishui
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China
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Luoyang
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China
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Nanchang
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China
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Nanjing
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China
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Nanyang
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China
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Ningbo
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China
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Qinhuangdao
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China
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Shanghai
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China
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Shijiazhuang
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China
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Suzhou
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China
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Xi'an
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China
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Xianyang
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China
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Zhenjiang
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Czechia
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Brno
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Czechia
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Havirov
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Czechia
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Karlovy Vary
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Czechia
State/province [106] 0 0
Nachod
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Czechia
State/province [107] 0 0
Olomouc
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Czechia
State/province [108] 0 0
Ostrava-Poruba
Country [109] 0 0
Czechia
State/province [109] 0 0
Plzen
Country [110] 0 0
Czechia
State/province [110] 0 0
Prague 2
Country [111] 0 0
Czechia
State/province [111] 0 0
Prague
Country [112] 0 0
Czechia
State/province [112] 0 0
Praha 8
Country [113] 0 0
Denmark
State/province [113] 0 0
Aarhus N
Country [114] 0 0
Denmark
State/province [114] 0 0
Copenhagen
Country [115] 0 0
Denmark
State/province [115] 0 0
Herlev
Country [116] 0 0
Denmark
State/province [116] 0 0
Herning
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Denmark
State/province [117] 0 0
Hvidovre
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Finland
State/province [118] 0 0
Helsinki
Country [119] 0 0
Finland
State/province [119] 0 0
Jyväskylä
Country [120] 0 0
Finland
State/province [120] 0 0
Pori
Country [121] 0 0
Finland
State/province [121] 0 0
Tampere
Country [122] 0 0
Finland
State/province [122] 0 0
Turku
Country [123] 0 0
Germany
State/province [123] 0 0
Aachen
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Germany
State/province [124] 0 0
Berlin
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Germany
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Düsseldorf
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Germany
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Erlangen
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Homburg
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Germany
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Kiel
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Germany
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Köln
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Germany
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Leipzig
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Germany
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Mainz
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Germany
State/province [136] 0 0
Münster
Country [137] 0 0
Germany
State/province [137] 0 0
Pohlheim
Country [138] 0 0
Germany
State/province [138] 0 0
Tübingen
Country [139] 0 0
Greece
State/province [139] 0 0
Athens
Country [140] 0 0
Greece
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Haidari-Athens
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Greece
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Heraklion, Crete
Country [142] 0 0
Greece
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Ioannina
Country [143] 0 0
Greece
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Larissa
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Greece
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P. Faliro
Country [145] 0 0
Greece
State/province [145] 0 0
Psychiko
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Greece
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Thessaloniki
Country [147] 0 0
Hong Kong
State/province [147] 0 0
Hong Kong
Country [148] 0 0
Hungary
State/province [148] 0 0
Baja
Country [149] 0 0
Hungary
State/province [149] 0 0
Budapest
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Hungary
State/province [150] 0 0
Debrecen
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Hungary
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Godollo
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Hungary
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Gyula
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Hungary
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Hatvan
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Hungary
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Kalocsa
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Hungary
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Kaposvar
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Hungary
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Zalaegerszeg
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India
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Aurangabad
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India
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Bikaner
Country [159] 0 0
India
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Chennai
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India
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Kanpur
Country [161] 0 0
India
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Maharashtra
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India
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New Delhi
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India
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Surat
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Ireland
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Dublin 4
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Ireland
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Galway
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Italy
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Bergamo
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Italy
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Latina
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Italy
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Milano
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Italy
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Palermo
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Italy
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Roma
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Italy
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Siena
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Italy
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Torino
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Japan
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Aichi, Nagoya
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Japan
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Chiba, Matsudo
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Japan
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Fukuoka, Okawa
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Japan
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Fukushima, Koriyama
Country [177] 0 0
Japan
State/province [177] 0 0
Kanagawa, Kawasaki
Country [178] 0 0
Japan
State/province [178] 0 0
Kanagawa, Sagamihara
Country [179] 0 0
Japan
State/province [179] 0 0
Kanagawa, Yokohama
Country [180] 0 0
Japan
State/province [180] 0 0
Kochi, Kochi
Country [181] 0 0
Japan
State/province [181] 0 0
Kyoto, Kuse-gun
Country [182] 0 0
Japan
State/province [182] 0 0
Mito, Ibaraki
Country [183] 0 0
Japan
State/province [183] 0 0
Miyagi, Sendai
Country [184] 0 0
Japan
State/province [184] 0 0
Okinawa, Urasoe
Country [185] 0 0
Japan
State/province [185] 0 0
Osaka, Osaka
Country [186] 0 0
Japan
State/province [186] 0 0
Saitama, Kawaguchi
Country [187] 0 0
Japan
State/province [187] 0 0
Saitama, Koshigaya
Country [188] 0 0
Japan
State/province [188] 0 0
Saitama, Sayama
Country [189] 0 0
Japan
State/province [189] 0 0
Shiga, Omihachiman
Country [190] 0 0
Japan
State/province [190] 0 0
Tokyo, Hachioji
Country [191] 0 0
Japan
State/province [191] 0 0
Tokyo, Suginami-ku
Country [192] 0 0
Japan
State/province [192] 0 0
Wakayama, Wakayama
Country [193] 0 0
Kazakhstan
State/province [193] 0 0
Almaty
Country [194] 0 0
Kazakhstan
State/province [194] 0 0
Astana
Country [195] 0 0
Korea, Republic of
State/province [195] 0 0
Busan
Country [196] 0 0
Korea, Republic of
State/province [196] 0 0
Cheongju
Country [197] 0 0
Korea, Republic of
State/province [197] 0 0
Daegu
Country [198] 0 0
Korea, Republic of
State/province [198] 0 0
Daejeon
Country [199] 0 0
Korea, Republic of
State/province [199] 0 0
Gwangju
Country [200] 0 0
Korea, Republic of
State/province [200] 0 0
Seongnam
Country [201] 0 0
Korea, Republic of
State/province [201] 0 0
Seoul
Country [202] 0 0
Korea, Republic of
State/province [202] 0 0
Wonju-si, Gangwon State
Country [203] 0 0
Mexico
State/province [203] 0 0
Chihuahua
Country [204] 0 0
Mexico
State/province [204] 0 0
Ciudad de Mexico
Country [205] 0 0
Mexico
State/province [205] 0 0
Cuernavaca
Country [206] 0 0
Mexico
State/province [206] 0 0
Culiacan
Country [207] 0 0
Mexico
State/province [207] 0 0
Monterrey
Country [208] 0 0
Mexico
State/province [208] 0 0
México
Country [209] 0 0
Netherlands
State/province [209] 0 0
Arnhem
Country [210] 0 0
Netherlands
State/province [210] 0 0
Haarlem
Country [211] 0 0
Netherlands
State/province [211] 0 0
Utrecht
Country [212] 0 0
Netherlands
State/province [212] 0 0
Veldhoven
Country [213] 0 0
New Zealand
State/province [213] 0 0
Migration Data
Country [214] 0 0
New Zealand
State/province [214] 0 0
Auckland
Country [215] 0 0
New Zealand
State/province [215] 0 0
Christchurch
Country [216] 0 0
New Zealand
State/province [216] 0 0
Lower Hutt
Country [217] 0 0
New Zealand
State/province [217] 0 0
Papatoetoe
Country [218] 0 0
New Zealand
State/province [218] 0 0
Rotorua
Country [219] 0 0
New Zealand
State/province [219] 0 0
Waikanae Beach
Country [220] 0 0
Norway
State/province [220] 0 0
Drammen
Country [221] 0 0
Norway
State/province [221] 0 0
Lørenskog
Country [222] 0 0
Norway
State/province [222] 0 0
Trondheim
Country [223] 0 0
Norway
State/province [223] 0 0
Tønsberg
Country [224] 0 0
Poland
State/province [224] 0 0
Bialystok
Country [225] 0 0
Poland
State/province [225] 0 0
Bydgoszcz
Country [226] 0 0
Poland
State/province [226] 0 0
Czestochowa
Country [227] 0 0
Poland
State/province [227] 0 0
Gdansk
Country [228] 0 0
Poland
State/province [228] 0 0
Gdynia
Country [229] 0 0
Poland
State/province [229] 0 0
Grudziadz
Country [230] 0 0
Poland
State/province [230] 0 0
Katowice
Country [231] 0 0
Poland
State/province [231] 0 0
Krakow
Country [232] 0 0
Poland
State/province [232] 0 0
Lodz
Country [233] 0 0
Poland
State/province [233] 0 0
Lublin
Country [234] 0 0
Poland
State/province [234] 0 0
Olsztyn
Country [235] 0 0
Poland
State/province [235] 0 0
Poznan
Country [236] 0 0
Poland
State/province [236] 0 0
Przemysl
Country [237] 0 0
Poland
State/province [237] 0 0
Rzeszow
Country [238] 0 0
Poland
State/province [238] 0 0
Skierniewice
Country [239] 0 0
Poland
State/province [239] 0 0
Sopot
Country [240] 0 0
Poland
State/province [240] 0 0
Staszow
Country [241] 0 0
Poland
State/province [241] 0 0
Swidnica
Country [242] 0 0
Poland
State/province [242] 0 0
Warsaw
Country [243] 0 0
Poland
State/province [243] 0 0
Warszawa
Country [244] 0 0
Poland
State/province [244] 0 0
Wroclaw
Country [245] 0 0
Portugal
State/province [245] 0 0
Alcabideche
Country [246] 0 0
Portugal
State/province [246] 0 0
Aveiro
Country [247] 0 0
Portugal
State/province [247] 0 0
Braga
Country [248] 0 0
Portugal
State/province [248] 0 0
Coimbra
Country [249] 0 0
Portugal
State/province [249] 0 0
Guimarães
Country [250] 0 0
Portugal
State/province [250] 0 0
Lisboa
Country [251] 0 0
Portugal
State/province [251] 0 0
Ponte de Lima
Country [252] 0 0
Portugal
State/province [252] 0 0
Santa Maria da Feira
Country [253] 0 0
Portugal
State/province [253] 0 0
Torres Novas
Country [254] 0 0
Portugal
State/province [254] 0 0
Vila Nova de Gaia
Country [255] 0 0
Puerto Rico
State/province [255] 0 0
Bayamon
Country [256] 0 0
Puerto Rico
State/province [256] 0 0
Ponce
Country [257] 0 0
Saudi Arabia
State/province [257] 0 0
Dammam
Country [258] 0 0
Saudi Arabia
State/province [258] 0 0
Jeddah
Country [259] 0 0
Saudi Arabia
State/province [259] 0 0
Riyadh
Country [260] 0 0
Slovakia
State/province [260] 0 0
Bratislava
Country [261] 0 0
Slovakia
State/province [261] 0 0
Kosice
Country [262] 0 0
Slovakia
State/province [262] 0 0
Lucenec
Country [263] 0 0
Slovakia
State/province [263] 0 0
Nove Zamky
Country [264] 0 0
Slovakia
State/province [264] 0 0
Roznava
Country [265] 0 0
Spain
State/province [265] 0 0
Alicante
Country [266] 0 0
Spain
State/province [266] 0 0
Badajoz
Country [267] 0 0
Spain
State/province [267] 0 0
Barcelona
Country [268] 0 0
Spain
State/province [268] 0 0
Bilbao
Country [269] 0 0
Spain
State/province [269] 0 0
Girona
Country [270] 0 0
Spain
State/province [270] 0 0
Granada
Country [271] 0 0
Spain
State/province [271] 0 0
Madrid
Country [272] 0 0
Spain
State/province [272] 0 0
Malaga
Country [273] 0 0
Spain
State/province [273] 0 0
Pozuelo de Alarcón
Country [274] 0 0
Spain
State/province [274] 0 0
Santander
Country [275] 0 0
Spain
State/province [275] 0 0
Santiago de Compostela
Country [276] 0 0
Spain
State/province [276] 0 0
Sevilla
Country [277] 0 0
Spain
State/province [277] 0 0
Valencia
Country [278] 0 0
Taiwan
State/province [278] 0 0
Changhua
Country [279] 0 0
Taiwan
State/province [279] 0 0
Chia-Yi City
Country [280] 0 0
Taiwan
State/province [280] 0 0
Taichung
Country [281] 0 0
Taiwan
State/province [281] 0 0
Tainan
Country [282] 0 0
Taiwan
State/province [282] 0 0
Taipei City
Country [283] 0 0
Taiwan
State/province [283] 0 0
Taoyuan County
Country [284] 0 0
Turkey
State/province [284] 0 0
Adana
Country [285] 0 0
Turkey
State/province [285] 0 0
Antalya
Country [286] 0 0
Turkey
State/province [286] 0 0
Battalgazi
Country [287] 0 0
Turkey
State/province [287] 0 0
Bursa
Country [288] 0 0
Turkey
State/province [288] 0 0
Diyarbakir
Country [289] 0 0
Turkey
State/province [289] 0 0
Istanbul
Country [290] 0 0
Turkey
State/province [290] 0 0
Kadiköy / Istanbul
Country [291] 0 0
Turkey
State/province [291] 0 0
Zonguldak
Country [292] 0 0
United Kingdom
State/province [292] 0 0
Airdrie
Country [293] 0 0
United Kingdom
State/province [293] 0 0
Antrim
Country [294] 0 0
United Kingdom
State/province [294] 0 0
Cardiff
Country [295] 0 0
United Kingdom
State/province [295] 0 0
Chorley
Country [296] 0 0
United Kingdom
State/province [296] 0 0
Dundee
Country [297] 0 0
United Kingdom
State/province [297] 0 0
Edgbaston
Country [298] 0 0
United Kingdom
State/province [298] 0 0
Edinburgh
Country [299] 0 0
United Kingdom
State/province [299] 0 0
Glasgow
Country [300] 0 0
United Kingdom
State/province [300] 0 0
Hexham
Country [301] 0 0
United Kingdom
State/province [301] 0 0
Leicester
Country [302] 0 0
United Kingdom
State/province [302] 0 0
Lincoln
Country [303] 0 0
United Kingdom
State/province [303] 0 0
Liverpool
Country [304] 0 0
United Kingdom
State/province [304] 0 0
Londonderry
Country [305] 0 0
United Kingdom
State/province [305] 0 0
London
Country [306] 0 0
United Kingdom
State/province [306] 0 0
Manchester
Country [307] 0 0
United Kingdom
State/province [307] 0 0
Newcastle upon Tyne
Country [308] 0 0
United Kingdom
State/province [308] 0 0
Swansea
Country [309] 0 0
United Kingdom
State/province [309] 0 0
Wishaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
clintriage.rdg@boehringer-ingelheim.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06077864