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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)
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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
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Secondary ID [1]
0
0
2022-502442-27-00
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Secondary ID [2]
0
0
1404-0040
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
0
0
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Condition category
Condition code
Diet and Nutrition
0
0
0
0
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Obesity
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Metabolic and Endocrine
0
0
0
0
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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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)
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Assessment method [1]
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Heart failure events (HFE) includes hospitalisation for heart failure (HHF), emergency room visit, urgent care visit, or urgent outpatient heart failure (HF) visit (5-point major adverse cardiac event (5P-MACE)) CV-Cardiovascular MI-Myocardial infarction
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Timepoint [1]
0
0
up to Week 114
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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)
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Assessment method [1]
0
0
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Timepoint [1]
0
0
up to Week 114
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Secondary outcome [2]
0
0
Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72
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Assessment method [2]
0
0
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Timepoint [2]
0
0
Baseline and at Week 72
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Secondary outcome [3]
0
0
Absolute change in waist circumference (cm) from baseline to Week 72
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Assessment method [3]
0
0
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Timepoint [3]
0
0
Baseline and at Week 72
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Secondary outcome [4]
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Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline
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Assessment method [4]
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KCCQ-TSCC scale score range is from 0 to 100 where low score means patient not doing well and higher score means patient doing better.
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Timepoint [4]
0
0
At Baseline and at Week 72
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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)
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Assessment method [5]
0
0
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Timepoint [5]
0
0
up to Week 114
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Secondary outcome [6]
0
0
Percentage change in body weight from baseline to Week 72
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Assessment method [6]
0
0
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Timepoint [6]
0
0
Baseline and at Week 72
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Secondary outcome [7]
0
0
Absolute change in diastolic blood pressure (DBP) (mmHg) from baseline to Week 72
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Assessment method [7]
0
0
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Timepoint [7]
0
0
Baseline and at Week 72
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Secondary outcome [8]
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Absolute change in aspartate aminotransferase (AST) (U/L) from baseline to Week 72
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Assessment method [8]
0
0
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Timepoint [8]
0
0
Baseline and at Week 72
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Secondary outcome [9]
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Absolute change in alanine aminotransferase (ALT) (U/L) from baseline to Week 72
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Assessment method [9]
0
0
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Timepoint [9]
0
0
Baseline and at Week 72
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Secondary outcome [10]
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Absolute change in glycosylated haemoglobin A1c (HbA1c) (mmol/mol) from baseline to Week 72 in trial participants with type 2 diabetes mellitus (T2DM)
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Assessment method [10]
0
0
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Timepoint [10]
0
0
Baseline and at Week 72
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Secondary outcome [11]
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Absolute change in HbA1c (%) from baseline to Week 72 in trial participants with T2DM
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Assessment method [11]
0
0
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Timepoint [11]
0
0
Baseline and at Week 72
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Secondary outcome [12]
0
0
Time to onset of T2DM in trial participants without T2DM at baseline
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Assessment method [12]
0
0
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Timepoint [12]
0
0
up to Week 114
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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))
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Assessment method [13]
0
0
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Timepoint [13]
0
0
up to Week 114
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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)
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Assessment method [14]
0
0
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Timepoint [14]
0
0
up to Week 114
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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)
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Assessment method [15]
0
0
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Timepoint [15]
0
0
up to Week 114
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Secondary outcome [16]
0
0
Time to first occurrence of adjudicated CV death or adjudicated HFE
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Assessment method [16]
0
0
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Timepoint [16]
0
0
up to Week 114
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Secondary outcome [17]
0
0
Time to first occurrence of adjudicated CV death or adjudicated HHF
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Assessment method [17]
0
0
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Timepoint [17]
0
0
up to Week 114
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Secondary outcome [18]
0
0
Time to first occurrence of adjudicated HFE
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Assessment method [18]
0
0
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Timepoint [18]
0
0
up to Week 114
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Secondary outcome [19]
0
0
Time to adjudicated CV death
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Assessment method [19]
0
0
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Timepoint [19]
0
0
up to Week 114
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Secondary outcome [20]
0
0
Time to all-cause mortality
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Assessment method [20]
0
0
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Timepoint [20]
0
0
up to Week 114
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Secondary outcome [21]
0
0
Time to first occurrence of adjudicated non-fatal MI
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Assessment method [21]
0
0
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Timepoint [21]
0
0
up to Week 114
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Secondary outcome [22]
0
0
Time to first occurrence of adjudicated non-fatal stroke
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Assessment method [22]
0
0
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Timepoint [22]
0
0
up to Week 114
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Secondary outcome [23]
0
0
Time to first occurrence of adjudicated ischaemia related coronary revascularisation
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Assessment method [23]
0
0
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Timepoint [23]
0
0
up to Week 114
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Secondary outcome [24]
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0
Achievement of body weight reduction =5% from baseline to Week 72
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Assessment method [24]
0
0
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Timepoint [24]
0
0
Baseline and at Week 72
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Secondary outcome [25]
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0
Achievement of body weight reduction =10% from baseline to Week 72
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Assessment method [25]
0
0
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Timepoint [25]
0
0
Baseline and at Week 72
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Secondary outcome [26]
0
0
Achievement of body weight reduction =15% from baseline to Week 72
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Assessment method [26]
0
0
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Timepoint [26]
0
0
Baseline and at Week 72
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Secondary outcome [27]
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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
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Assessment method [27]
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Win ratio will be assessed as below:
The primary efficacy endpoint will be analyzed using the clinical benefit approach comparing every participant in the BI 456906 arm to every participant in the placebo arm to determine a winner.
A winner in the pair-wise comparison has a delayed time to the occurrence of death; if that cannot be determined, a winner has fewer HFEs; if the number of HFEs is the same a winner has a delayed time to the occurrence of first HFE; if that rule does not determine a winner, a winner has a more favorable (less increase or more decrease) change in KCCQ-CSS between baseline and at 72 weeks, otherwise the pair will be recorded as tied. The estimated net benefit (win ratio is then calculated as the total number of wins in the BI 456906 group across all strata divided by the total number of losses) will be provided.
KCCQ-TSCC scale score range is from 0 to 100 where low score means patient not doing well and higher score means patient doing better.
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Timepoint [27]
0
0
At baseline and at 72 Weeks
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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.
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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. 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.
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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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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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
Recruiting
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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
17/11/2023
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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
2/04/2026
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Actual
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Sample size
Target
4935
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
0
0
The Boden Initiative - Camperdown
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Recruitment hospital [2]
0
0
Novatrials - Kotara
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Recruitment hospital [3]
0
0
Royal North Shore Hospital - St Leonards
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Recruitment hospital [4]
0
0
AusTrials - Taringa - Taringa
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Recruitment hospital [5]
0
0
AusTrials - Wellers Hill
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Recruitment hospital [6]
0
0
Royal Adelaide Hospital - Adelaide
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Recruitment hospital [7]
0
0
Repatriation General Hospital - Daw Park
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Recruitment hospital [8]
0
0
Advara Heart Care - Leabrook
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Recruitment hospital [9]
0
0
Victorian Heart Hospital - Clayton
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Recruitment hospital [10]
0
0
Royal Melbourne Hospital - Parkville
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Recruitment hospital [11]
0
0
Advara Heart Care - Joondalup
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Recruitment postcode(s) [1]
0
0
2006 - Camperdown
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Recruitment postcode(s) [2]
0
0
2289 - Kotara
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Recruitment postcode(s) [3]
0
0
2065 - St Leonards
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Recruitment postcode(s) [4]
0
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4068 - Taringa
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Recruitment postcode(s) [5]
0
0
4121 - Wellers Hill
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Recruitment postcode(s) [6]
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5000 - Adelaide
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Recruitment postcode(s) [7]
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0
5041 - Daw Park
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Recruitment postcode(s) [8]
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5068 - Leabrook
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Recruitment postcode(s) [9]
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0
3168 - Clayton
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Recruitment postcode(s) [10]
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3050 - Parkville
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Recruitment postcode(s) [11]
0
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6027 - Joondalup
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Arkansas
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Country [4]
0
0
United States of America
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State/province [4]
0
0
California
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Colorado
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Connecticut
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Florida
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Georgia
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Country [9]
0
0
United States of America
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State/province [9]
0
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Illinois
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Indiana
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Iowa
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Kansas
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Kentucky
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Louisiana
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Maryland
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Massachusetts
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Country [17]
0
0
United States of America
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State/province [17]
0
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Michigan
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Country [18]
0
0
United States of America
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State/province [18]
0
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Minnesota
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Country [19]
0
0
United States of America
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State/province [19]
0
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Mississippi
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Country [20]
0
0
United States of America
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State/province [20]
0
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Missouri
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Country [21]
0
0
United States of America
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State/province [21]
0
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Montana
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Country [22]
0
0
United States of America
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State/province [22]
0
0
Nebraska
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Country [23]
0
0
United States of America
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State/province [23]
0
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Nevada
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Country [24]
0
0
United States of America
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State/province [24]
0
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New Jersey
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Country [25]
0
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United States of America
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State/province [25]
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New Mexico
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Country [26]
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United States of America
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State/province [26]
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New York
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Country [27]
0
0
United States of America
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State/province [27]
0
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North Carolina
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Country [28]
0
0
United States of America
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State/province [28]
0
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Ohio
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Country [29]
0
0
United States of America
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State/province [29]
0
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Oklahoma
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Country [30]
0
0
United States of America
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State/province [30]
0
0
Oregon
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Country [31]
0
0
United States of America
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State/province [31]
0
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Pennsylvania
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0
0
United States of America
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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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United States of America
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Washington
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0
0
United States of America
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State/province [39]
0
0
Wisconsin
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Country [40]
0
0
Argentina
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State/province [40]
0
0
Caba
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Country [41]
0
0
Argentina
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State/province [41]
0
0
Ciudad Autonoma Buenos Aires
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0
0
Argentina
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State/province [42]
0
0
Ciudad Autonoma de Bs As
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0
0
Argentina
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0
Ciudad Autónoma de Bs As
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Country [44]
0
0
Argentina
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State/province [44]
0
0
Ciudad Autónoma de Buenos Aire
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0
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Argentina
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0
0
Córdoba
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0
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Argentina
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State/province [46]
0
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Mar del Plata
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Country [47]
0
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Argentina
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State/province [47]
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Parque Velez Sarfield
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Country [48]
0
0
Argentina
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State/province [48]
0
0
Villa Luro
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Country [49]
0
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Austria
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State/province [49]
0
0
Graz
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Country [50]
0
0
Austria
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0
0
Innsbruck
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Country [51]
0
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Austria
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State/province [51]
0
0
Linz
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Country [52]
0
0
Austria
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State/province [52]
0
0
Salzburg
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Country [53]
0
0
Austria
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State/province [53]
0
0
Stockerau
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Country [54]
0
0
Austria
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State/province [54]
0
0
Vienna
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Country [55]
0
0
Belgium
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State/province [55]
0
0
Brugge
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Country [56]
0
0
Belgium
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State/province [56]
0
0
Edegem
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Country [57]
0
0
Belgium
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State/province [57]
0
0
Leuven
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Country [58]
0
0
Brazil
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State/province [58]
0
0
Belém
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Country [59]
0
0
Brazil
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State/province [59]
0
0
Brasilia
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Country [60]
0
0
Brazil
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State/province [60]
0
0
Brasília
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Country [61]
0
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Brazil
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State/province [61]
0
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Curitiba
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Country [62]
0
0
Brazil
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State/province [62]
0
0
Fortaleza
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Country [63]
0
0
Brazil
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State/province [63]
0
0
Porto Alegre
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Country [64]
0
0
Brazil
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State/province [64]
0
0
Rio de Janeiro
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Country [65]
0
0
Brazil
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State/province [65]
0
0
Sao Paulo
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Country [66]
0
0
Brazil
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State/province [66]
0
0
São José dos Campos
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Country [67]
0
0
Brazil
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State/province [67]
0
0
São Paulo
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Country [68]
0
0
Bulgaria
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State/province [68]
0
0
Byala
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Country [69]
0
0
Bulgaria
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State/province [69]
0
0
Dobrich
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Country [70]
0
0
Bulgaria
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State/province [70]
0
0
Dupnitsa
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Country [71]
0
0
Bulgaria
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State/province [71]
0
0
Plovdiv
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Country [72]
0
0
Bulgaria
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State/province [72]
0
0
Sliven
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Country [73]
0
0
Bulgaria
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State/province [73]
0
0
Sofia
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Country [74]
0
0
Bulgaria
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State/province [74]
0
0
Yambol
Query!
Country [75]
0
0
Canada
Query!
State/province [75]
0
0
Alberta
Query!
Country [76]
0
0
Canada
Query!
State/province [76]
0
0
British Columbia
Query!
Country [77]
0
0
Canada
Query!
State/province [77]
0
0
Manitoba
Query!
Country [78]
0
0
Canada
Query!
State/province [78]
0
0
Nova Scotia
Query!
Country [79]
0
0
Canada
Query!
State/province [79]
0
0
Ontario
Query!
Country [80]
0
0
Canada
Query!
State/province [80]
0
0
Quebec
Query!
Country [81]
0
0
Canada
Query!
State/province [81]
0
0
Oakville
Query!
Country [82]
0
0
China
Query!
State/province [82]
0
0
Beijing
Query!
Country [83]
0
0
China
Query!
State/province [83]
0
0
Changchun
Query!
Country [84]
0
0
China
Query!
State/province [84]
0
0
Changzhou
Query!
Country [85]
0
0
China
Query!
State/province [85]
0
0
Chongqing
Query!
Country [86]
0
0
China
Query!
State/province [86]
0
0
Hangzhou
Query!
Country [87]
0
0
China
Query!
State/province [87]
0
0
Harbin
Query!
Country [88]
0
0
China
Query!
State/province [88]
0
0
Hengyang
Query!
Country [89]
0
0
China
Query!
State/province [89]
0
0
Huai'an
Query!
Country [90]
0
0
China
Query!
State/province [90]
0
0
Huzhou
Query!
Country [91]
0
0
China
Query!
State/province [91]
0
0
Jinan
Query!
Country [92]
0
0
China
Query!
State/province [92]
0
0
Lishui
Query!
Country [93]
0
0
China
Query!
State/province [93]
0
0
Luoyang
Query!
Country [94]
0
0
China
Query!
State/province [94]
0
0
Nanchang
Query!
Country [95]
0
0
China
Query!
State/province [95]
0
0
Nanjing
Query!
Country [96]
0
0
China
Query!
State/province [96]
0
0
Nanyang
Query!
Country [97]
0
0
China
Query!
State/province [97]
0
0
Ningbo
Query!
Country [98]
0
0
China
Query!
State/province [98]
0
0
Qinhuangdao
Query!
Country [99]
0
0
China
Query!
State/province [99]
0
0
Shanghai
Query!
Country [100]
0
0
China
Query!
State/province [100]
0
0
Shijiazhuang
Query!
Country [101]
0
0
China
Query!
State/province [101]
0
0
Suzhou
Query!
Country [102]
0
0
China
Query!
State/province [102]
0
0
Xi'an
Query!
Country [103]
0
0
China
Query!
State/province [103]
0
0
Xianyang
Query!
Country [104]
0
0
China
Query!
State/province [104]
0
0
Zhenjiang
Query!
Country [105]
0
0
Czechia
Query!
State/province [105]
0
0
Brno
Query!
Country [106]
0
0
Czechia
Query!
State/province [106]
0
0
Havirov
Query!
Country [107]
0
0
Czechia
Query!
State/province [107]
0
0
Karlovy Vary
Query!
Country [108]
0
0
Czechia
Query!
State/province [108]
0
0
Nachod
Query!
Country [109]
0
0
Czechia
Query!
State/province [109]
0
0
Olomouc
Query!
Country [110]
0
0
Czechia
Query!
State/province [110]
0
0
Ostrava-Poruba
Query!
Country [111]
0
0
Czechia
Query!
State/province [111]
0
0
Plzen
Query!
Country [112]
0
0
Czechia
Query!
State/province [112]
0
0
Prague 2
Query!
Country [113]
0
0
Czechia
Query!
State/province [113]
0
0
Prague
Query!
Country [114]
0
0
Czechia
Query!
State/province [114]
0
0
Praha 8
Query!
Country [115]
0
0
Denmark
Query!
State/province [115]
0
0
Aarhus N
Query!
Country [116]
0
0
Denmark
Query!
State/province [116]
0
0
Copenhagen
Query!
Country [117]
0
0
Denmark
Query!
State/province [117]
0
0
Herlev
Query!
Country [118]
0
0
Denmark
Query!
State/province [118]
0
0
Herning
Query!
Country [119]
0
0
Denmark
Query!
State/province [119]
0
0
Hvidovre
Query!
Country [120]
0
0
Finland
Query!
State/province [120]
0
0
Helsinki
Query!
Country [121]
0
0
Finland
Query!
State/province [121]
0
0
Jyväskylä
Query!
Country [122]
0
0
Finland
Query!
State/province [122]
0
0
Pori
Query!
Country [123]
0
0
Finland
Query!
State/province [123]
0
0
Tampere
Query!
Country [124]
0
0
Finland
Query!
State/province [124]
0
0
Turku
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Aachen
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Berlin
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Düsseldorf
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
Erlangen
Query!
Country [129]
0
0
Germany
Query!
State/province [129]
0
0
Frankfurt am Main
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Frankfurt
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
Freiburg
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Hannover
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Heidelberg
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Homburg
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Kiel
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Köln
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Leipzig
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Magdeburg
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Mainz
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Münster
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Pohlheim
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Regensburg
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Tübingen
Query!
Country [144]
0
0
Greece
Query!
State/province [144]
0
0
Athens
Query!
Country [145]
0
0
Greece
Query!
State/province [145]
0
0
Haidari-Athens
Query!
Country [146]
0
0
Greece
Query!
State/province [146]
0
0
Heraklion, Crete
Query!
Country [147]
0
0
Greece
Query!
State/province [147]
0
0
Ioannina
Query!
Country [148]
0
0
Greece
Query!
State/province [148]
0
0
Larissa
Query!
Country [149]
0
0
Greece
Query!
State/province [149]
0
0
P. Faliro
Query!
Country [150]
0
0
Greece
Query!
State/province [150]
0
0
Psychiko
Query!
Country [151]
0
0
Greece
Query!
State/province [151]
0
0
Thessaloniki
Query!
Country [152]
0
0
Hong Kong
Query!
State/province [152]
0
0
Hong Kong
Query!
Country [153]
0
0
Hungary
Query!
State/province [153]
0
0
Baja
Query!
Country [154]
0
0
Hungary
Query!
State/province [154]
0
0
Budapest
Query!
Country [155]
0
0
Hungary
Query!
State/province [155]
0
0
Debrecen
Query!
Country [156]
0
0
Hungary
Query!
State/province [156]
0
0
Godollo
Query!
Country [157]
0
0
Hungary
Query!
State/province [157]
0
0
Gyula
Query!
Country [158]
0
0
Hungary
Query!
State/province [158]
0
0
Hatvan
Query!
Country [159]
0
0
Hungary
Query!
State/province [159]
0
0
Kalocsa
Query!
Country [160]
0
0
Hungary
Query!
State/province [160]
0
0
Kaposvar
Query!
Country [161]
0
0
Hungary
Query!
State/province [161]
0
0
Zalaegerszeg
Query!
Country [162]
0
0
India
Query!
State/province [162]
0
0
Aurangabad
Query!
Country [163]
0
0
India
Query!
State/province [163]
0
0
Bikaner
Query!
Country [164]
0
0
India
Query!
State/province [164]
0
0
Chennai
Query!
Country [165]
0
0
India
Query!
State/province [165]
0
0
Kanpur
Query!
Country [166]
0
0
India
Query!
State/province [166]
0
0
Maharashtra
Query!
Country [167]
0
0
India
Query!
State/province [167]
0
0
New Delhi
Query!
Country [168]
0
0
India
Query!
State/province [168]
0
0
Surat
Query!
Country [169]
0
0
Ireland
Query!
State/province [169]
0
0
Dublin 4
Query!
Country [170]
0
0
Ireland
Query!
State/province [170]
0
0
Galway
Query!
Country [171]
0
0
Italy
Query!
State/province [171]
0
0
Bergamo
Query!
Country [172]
0
0
Italy
Query!
State/province [172]
0
0
Latina
Query!
Country [173]
0
0
Italy
Query!
State/province [173]
0
0
Milano
Query!
Country [174]
0
0
Italy
Query!
State/province [174]
0
0
Palermo
Query!
Country [175]
0
0
Italy
Query!
State/province [175]
0
0
Roma
Query!
Country [176]
0
0
Italy
Query!
State/province [176]
0
0
Siena
Query!
Country [177]
0
0
Italy
Query!
State/province [177]
0
0
Torino
Query!
Country [178]
0
0
Japan
Query!
State/province [178]
0
0
Aichi, Nagoya
Query!
Country [179]
0
0
Japan
Query!
State/province [179]
0
0
Chiba, Matsudo
Query!
Country [180]
0
0
Japan
Query!
State/province [180]
0
0
Fukuoka, Okawa
Query!
Country [181]
0
0
Japan
Query!
State/province [181]
0
0
Fukushima, Koriyama
Query!
Country [182]
0
0
Japan
Query!
State/province [182]
0
0
Kanagawa, Kawasaki
Query!
Country [183]
0
0
Japan
Query!
State/province [183]
0
0
Kanagawa, Sagamihara
Query!
Country [184]
0
0
Japan
Query!
State/province [184]
0
0
Kanagawa, Yokohama
Query!
Country [185]
0
0
Japan
Query!
State/province [185]
0
0
Kochi, Kochi
Query!
Country [186]
0
0
Japan
Query!
State/province [186]
0
0
Kyoto, Kuse-gun
Query!
Country [187]
0
0
Japan
Query!
State/province [187]
0
0
Mito, Ibaraki
Query!
Country [188]
0
0
Japan
Query!
State/province [188]
0
0
Miyagi, Sendai
Query!
Country [189]
0
0
Japan
Query!
State/province [189]
0
0
Okinawa, Urasoe
Query!
Country [190]
0
0
Japan
Query!
State/province [190]
0
0
Osaka, Osaka
Query!
Country [191]
0
0
Japan
Query!
State/province [191]
0
0
Saitama, Kawaguchi
Query!
Country [192]
0
0
Japan
Query!
State/province [192]
0
0
Saitama, Koshigaya
Query!
Country [193]
0
0
Japan
Query!
State/province [193]
0
0
Saitama, Sayama
Query!
Country [194]
0
0
Japan
Query!
State/province [194]
0
0
Shiga, Omihachiman
Query!
Country [195]
0
0
Japan
Query!
State/province [195]
0
0
Tokyo, Hachioji
Query!
Country [196]
0
0
Japan
Query!
State/province [196]
0
0
Tokyo, Suginami-ku
Query!
Country [197]
0
0
Japan
Query!
State/province [197]
0
0
Wakayama, Wakayama
Query!
Country [198]
0
0
Kazakhstan
Query!
State/province [198]
0
0
Almaty
Query!
Country [199]
0
0
Kazakhstan
Query!
State/province [199]
0
0
Astana
Query!
Country [200]
0
0
Korea, Republic of
Query!
State/province [200]
0
0
Busan
Query!
Country [201]
0
0
Korea, Republic of
Query!
State/province [201]
0
0
Cheongju
Query!
Country [202]
0
0
Korea, Republic of
Query!
State/province [202]
0
0
Daegu
Query!
Country [203]
0
0
Korea, Republic of
Query!
State/province [203]
0
0
Daejeon
Query!
Country [204]
0
0
Korea, Republic of
Query!
State/province [204]
0
0
Gwangju
Query!
Country [205]
0
0
Korea, Republic of
Query!
State/province [205]
0
0
Seongnam
Query!
Country [206]
0
0
Korea, Republic of
Query!
State/province [206]
0
0
Seoul
Query!
Country [207]
0
0
Korea, Republic of
Query!
State/province [207]
0
0
Wonju-si, Gangwon State
Query!
Country [208]
0
0
Mexico
Query!
State/province [208]
0
0
Chihuahua
Query!
Country [209]
0
0
Mexico
Query!
State/province [209]
0
0
Ciudad de Mexico
Query!
Country [210]
0
0
Mexico
Query!
State/province [210]
0
0
Cuernavaca
Query!
Country [211]
0
0
Mexico
Query!
State/province [211]
0
0
Culiacan
Query!
Country [212]
0
0
Mexico
Query!
State/province [212]
0
0
Monterrey
Query!
Country [213]
0
0
Mexico
Query!
State/province [213]
0
0
México
Query!
Country [214]
0
0
Netherlands
Query!
State/province [214]
0
0
Arnhem
Query!
Country [215]
0
0
Netherlands
Query!
State/province [215]
0
0
Haarlem
Query!
Country [216]
0
0
Netherlands
Query!
State/province [216]
0
0
Utrecht
Query!
Country [217]
0
0
Netherlands
Query!
State/province [217]
0
0
Veldhoven
Query!
Country [218]
0
0
New Zealand
Query!
State/province [218]
0
0
Migration Data
Query!
Country [219]
0
0
New Zealand
Query!
State/province [219]
0
0
Auckland
Query!
Country [220]
0
0
New Zealand
Query!
State/province [220]
0
0
Christchurch
Query!
Country [221]
0
0
New Zealand
Query!
State/province [221]
0
0
Lower Hutt
Query!
Country [222]
0
0
New Zealand
Query!
State/province [222]
0
0
Papatoetoe
Query!
Country [223]
0
0
New Zealand
Query!
State/province [223]
0
0
Paraparaumu
Query!
Country [224]
0
0
New Zealand
Query!
State/province [224]
0
0
Rotorua
Query!
Country [225]
0
0
Norway
Query!
State/province [225]
0
0
Drammen
Query!
Country [226]
0
0
Norway
Query!
State/province [226]
0
0
Lørenskog
Query!
Country [227]
0
0
Norway
Query!
State/province [227]
0
0
Trondheim
Query!
Country [228]
0
0
Norway
Query!
State/province [228]
0
0
Tønsberg
Query!
Country [229]
0
0
Poland
Query!
State/province [229]
0
0
Bialystok
Query!
Country [230]
0
0
Poland
Query!
State/province [230]
0
0
Bydgoszcz
Query!
Country [231]
0
0
Poland
Query!
State/province [231]
0
0
Czestochowa
Query!
Country [232]
0
0
Poland
Query!
State/province [232]
0
0
Gdansk
Query!
Country [233]
0
0
Poland
Query!
State/province [233]
0
0
Gdynia
Query!
Country [234]
0
0
Poland
Query!
State/province [234]
0
0
Grudziadz
Query!
Country [235]
0
0
Poland
Query!
State/province [235]
0
0
Katowice
Query!
Country [236]
0
0
Poland
Query!
State/province [236]
0
0
Krakow
Query!
Country [237]
0
0
Poland
Query!
State/province [237]
0
0
Lodz
Query!
Country [238]
0
0
Poland
Query!
State/province [238]
0
0
Lublin
Query!
Country [239]
0
0
Poland
Query!
State/province [239]
0
0
Olsztyn
Query!
Country [240]
0
0
Poland
Query!
State/province [240]
0
0
Poznan
Query!
Country [241]
0
0
Poland
Query!
State/province [241]
0
0
Przemysl
Query!
Country [242]
0
0
Poland
Query!
State/province [242]
0
0
Rzeszow
Query!
Country [243]
0
0
Poland
Query!
State/province [243]
0
0
Skierniewice
Query!
Country [244]
0
0
Poland
Query!
State/province [244]
0
0
Sopot
Query!
Country [245]
0
0
Poland
Query!
State/province [245]
0
0
Staszow
Query!
Country [246]
0
0
Poland
Query!
State/province [246]
0
0
Swidnica
Query!
Country [247]
0
0
Poland
Query!
State/province [247]
0
0
Warsaw
Query!
Country [248]
0
0
Poland
Query!
State/province [248]
0
0
Warszawa
Query!
Country [249]
0
0
Poland
Query!
State/province [249]
0
0
Wroclaw
Query!
Country [250]
0
0
Portugal
Query!
State/province [250]
0
0
Alcabideche
Query!
Country [251]
0
0
Portugal
Query!
State/province [251]
0
0
Aveiro
Query!
Country [252]
0
0
Portugal
Query!
State/province [252]
0
0
Braga
Query!
Country [253]
0
0
Portugal
Query!
State/province [253]
0
0
Coimbra
Query!
Country [254]
0
0
Portugal
Query!
State/province [254]
0
0
Guimarães
Query!
Country [255]
0
0
Portugal
Query!
State/province [255]
0
0
Lisboa
Query!
Country [256]
0
0
Portugal
Query!
State/province [256]
0
0
Ponte de Lima
Query!
Country [257]
0
0
Portugal
Query!
State/province [257]
0
0
Santa Maria da Feira
Query!
Country [258]
0
0
Portugal
Query!
State/province [258]
0
0
Torres Novas
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Portugal
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Vila Nova de Gaia
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Puerto Rico
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Bayamon
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Puerto Rico
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Ponce
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Saudi Arabia
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Dammam
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Saudi Arabia
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Jeddah
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Saudi Arabia
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Riyadh
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Lucenec
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Slovakia
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Nove Zamky
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Slovakia
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Roznava
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Spain
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Alicante
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Spain
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Badajoz
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Spain
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Barcelona
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Spain
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Bilbao
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Spain
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Girona
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Spain
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Granada
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Pozuelo de Alarcón
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Spain
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Santander
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Spain
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Santiago de Compostela
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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Changhua
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Taiwan
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taoyuan County
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Turkey
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Adana
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Turkey
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Antalya
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Turkey
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Battalgazi
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Turkey
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Bursa
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Turkey
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Diyarbakir
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Turkey
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Istanbul
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Turkey
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Zonguldak
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United Kingdom
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Airdrie
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United Kingdom
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Antrim
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United Kingdom
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Cardiff
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United Kingdom
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Chorley
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United Kingdom
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Dundee
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United Kingdom
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Edgbaston
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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Hexham
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United Kingdom
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Leicester
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United Kingdom
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Lincoln
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United Kingdom
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Liverpool
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United Kingdom
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Londonderry
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Swansea
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United Kingdom
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Wishaw
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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
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Summary
Brief summary
This study is open to adults who are at least 18 years old and have a body mass index (BMI)bof 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet. The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight. Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity. Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.
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Trial website
https://clinicaltrials.gov/study/NCT06077864
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Boehringer Ingelheim
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Phone
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1-800-243-0127
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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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.
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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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing
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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