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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05757869




Registration number
NCT05757869
Ethics application status
Date submitted
24/02/2023
Date registered
7/03/2023

Titles & IDs
Public title
A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
Scientific title
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation
Secondary ID [1] 0 0
70033093AFL3002
Secondary ID [2] 0 0
CR109220
Universal Trial Number (UTN)
Trial acronym
LIBREXIA-AF
Linked study record

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

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

Experimental: Milvexian - Participants will receive milvexian 100 milligrams (mg) orally, twice daily and placebo that matches apixaban beginning on Day 1 through end of treatment (EOT). Participants after the EOT visit may have an option to receive open-label apixaban at the appropriate dose (5 mg or 2.5 mg, twice daily), for which the sponsor provides a 30-day supply.

Active comparator: Apixaban - Participants will receive a placebo that matches milvexian and a capsule containing apixaban 5 mg or 2.5 mg orally, twice daily. Participants after the EOT visit may have an option to receive open-label apixaban (5 mg or 2.5 mg, twice daily) at the appropriate dose, for which the sponsor provides a 30-day supply.


Treatment: Drugs: Milvexian
Milvexian will be administered orally.

Treatment: Drugs: Apixaban
Apixaban will be administered orally.

Treatment: Drugs: Placebo
Milvexian matching milvexian placebo will be administered orally.

Treatment: Drugs: Apixaban Placebo
Apixaban matching apixaban placebo will be administered orally.

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

Outcomes
Primary outcome [1] 0 0
Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Time to the First Occurrence of International Society of Thrombosis and Hemostasis (ISTH) Major Bleeding
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
Time to the First Occurrence of the Composite of ISTH Major and Clinically Relevant Non-major (CRNM) Bleeding
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
Time to the First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, and Non-CNS Systemic Embolism
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Time to CV Death
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Time to the First Occurrence of Composite Endpoint of All-cause Death, MI, Stroke and Non-CNS Systemic Embolism
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Time to the First Occurrence of Composite Endpoint of CV Death, MI, Stroke, Acute Limb Ischemia (ALI), and Urgent Hospitalization for Vascular cause of Ischemic Nature
Timepoint [6] 0 0
Up to 4 years

Eligibility
Key inclusion criteria
* Minimum age of 18 years
* Medically stable and appropriate for chronic antithrombotic treatment
* Atrial fibrillation eligible to receive anticoagulation
* Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the following risk factors: i) age greater than or equal to 75 years, ii) history of any type of stroke including symptomatic stroke of any kind. b) two or more of the following risk factors: i) age between 65 and 74 years, ii) hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v) heart failure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study
* Any condition other than AF that requires chronic anticoagulation

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 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Advara HeartCare Wesley - Brisbane
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
Peninsula Heart Center - Frankston
Recruitment hospital [5] 0 0
The Canberra Hospital - Garran
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [7] 0 0
GenesisCare Joondalup-Shenton House - Joondalup
Recruitment hospital [8] 0 0
Novatrials - Kotara
Recruitment hospital [9] 0 0
GenesisCare - Leabrook
Recruitment hospital [10] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [11] 0 0
Core Research Group - Milton
Recruitment hospital [12] 0 0
Brisbane Health Connect - Tarragindi
Recruitment postcode(s) [1] 0 0
5042 - Adelaide
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4066 - Brisbane
Recruitment postcode(s) [3] 0 0
2139 - Concord
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3199 - Frankston
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2605 - Garran
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4029 - Herston
Recruitment postcode(s) [7] 0 0
6027 - Joondalup
Recruitment postcode(s) [8] 0 0
2289 - Kotara
Recruitment postcode(s) [9] 0 0
5068 - Leabrook
Recruitment postcode(s) [10] 0 0
2170 - Liverpool
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4064 - Milton
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4121 - Tarragindi
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Tallinn
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France
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Angers Cedex 9
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France
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Bayonne Cedex
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France
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France
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France
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Bron cedex
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France
State/province [224] 0 0
Corbeil Essonnes cedex
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France
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France
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Dijon cedex
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France
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France
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France
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Marseille cedex
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France
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France
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Nice Cedex 1
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France
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Paris Cedex 12
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France
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Paris
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France
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Pau
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France
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Pessac
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France
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France
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Rouen cedex
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France
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Rouen
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France
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Germany
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Germany
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Bad Friedrichshall
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Germany
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Bad Homburg
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Germany
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Bad Oeynhausen
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Germany
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Germany
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Germany
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Bielefeld
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Germany
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Bonn-Beuel
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Germany
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Germany
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Dachau
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Germany
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Deggingen
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Germany
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Dessau-Rosslau
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Germany
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Dresden
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Germany
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Germany
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Germany
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Frankfurt
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Germany
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Germany
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Germany
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Kassel
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Germany
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Kiel
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Germany
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Germany
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Germany
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Mannheim
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Worms
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Germany
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Wuppertal
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Kallithea
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Patras
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Greece
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Hungary
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Baja
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Hungary
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Balatonfured
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Hungary
State/province [279] 0 0
Bekescsaba
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Hungary
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Budapest
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Hungary
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Hungary
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Country [283] 0 0
Hungary
State/province [283] 0 0
Gyula
Country [284] 0 0
Hungary
State/province [284] 0 0
Hatvan
Country [285] 0 0
Hungary
State/province [285] 0 0
Hodmezovasarhely
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Hungary
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Kaposvar
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Hungary
State/province [287] 0 0
Kecskemet
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Hungary
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Komarom
Country [289] 0 0
Hungary
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Miskolc
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Hungary
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Mosonmagyarovar
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Hungary
State/province [291] 0 0
Nyiregyhaza
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Hungary
State/province [292] 0 0
Oroshaza
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Hungary
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Pecs
Country [294] 0 0
Hungary
State/province [294] 0 0
Szeged
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Hungary
State/province [295] 0 0
Szekesfehervar
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Hungary
State/province [296] 0 0
Szolnok
Country [297] 0 0
Hungary
State/province [297] 0 0
Szombathely
Country [298] 0 0
Hungary
State/province [298] 0 0
Zalaegerszeg
Country [299] 0 0
India
State/province [299] 0 0
Aligarh
Country [300] 0 0
India
State/province [300] 0 0
Amritsar
Country [301] 0 0
India
State/province [301] 0 0
Aurangabad
Country [302] 0 0
India
State/province [302] 0 0
Bangalore
Country [303] 0 0
India
State/province [303] 0 0
Belgaum
Country [304] 0 0
India
State/province [304] 0 0
Bengaluru
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India
State/province [305] 0 0
Bikaner
Country [306] 0 0
India
State/province [306] 0 0
Chennai
Country [307] 0 0
India
State/province [307] 0 0
Cochin
Country [308] 0 0
India
State/province [308] 0 0
Jaipur
Country [309] 0 0
India
State/province [309] 0 0
Karamsad
Country [310] 0 0
India
State/province [310] 0 0
Kolkata
Country [311] 0 0
India
State/province [311] 0 0
Nagar
Country [312] 0 0
India
State/province [312] 0 0
Nagpur
Country [313] 0 0
India
State/province [313] 0 0
Nashik
Country [314] 0 0
India
State/province [314] 0 0
New Delhi
Country [315] 0 0
India
State/province [315] 0 0
Pune
Country [316] 0 0
India
State/province [316] 0 0
Secunderabad
Country [317] 0 0
India
State/province [317] 0 0
Shivamogga
Country [318] 0 0
India
State/province [318] 0 0
Vijayawada
Country [319] 0 0
India
State/province [319] 0 0
Vishakhapatnam
Country [320] 0 0
Israel
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Country [321] 0 0
Israel
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Country [322] 0 0
Israel
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Haifa
Country [323] 0 0
Israel
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Holon
Country [324] 0 0
Israel
State/province [324] 0 0
Jerusalem
Country [325] 0 0
Israel
State/province [325] 0 0
Kfar Sava
Country [326] 0 0
Israel
State/province [326] 0 0
Nazareth
Country [327] 0 0
Israel
State/province [327] 0 0
Petah Tikva
Country [328] 0 0
Israel
State/province [328] 0 0
Ramat Gan
Country [329] 0 0
Israel
State/province [329] 0 0
Rechovot
Country [330] 0 0
Israel
State/province [330] 0 0
Rishon Lezion
Country [331] 0 0
Israel
State/province [331] 0 0
Safed
Country [332] 0 0
Israel
State/province [332] 0 0
Yerushalayim
Country [333] 0 0
Italy
State/province [333] 0 0
Arezzo
Country [334] 0 0
Italy
State/province [334] 0 0
Aversa
Country [335] 0 0
Italy
State/province [335] 0 0
Bergamo
Country [336] 0 0
Italy
State/province [336] 0 0
Bologna
Country [337] 0 0
Italy
State/province [337] 0 0
Caserta
Country [338] 0 0
Italy
State/province [338] 0 0
Catania
Country [339] 0 0
Italy
State/province [339] 0 0
Catanzaro
Country [340] 0 0
Italy
State/province [340] 0 0
Ferrara
Country [341] 0 0
Italy
State/province [341] 0 0
Lecco
Country [342] 0 0
Italy
State/province [342] 0 0
Massa
Country [343] 0 0
Italy
State/province [343] 0 0
Milano
Country [344] 0 0
Italy
State/province [344] 0 0
Modena
Country [345] 0 0
Italy
State/province [345] 0 0
Monza
Country [346] 0 0
Italy
State/province [346] 0 0
Pavia
Country [347] 0 0
Italy
State/province [347] 0 0
Perugia
Country [348] 0 0
Italy
State/province [348] 0 0
Pisa
Country [349] 0 0
Italy
State/province [349] 0 0
Roma
Country [350] 0 0
Italy
State/province [350] 0 0
Rozzano
Country [351] 0 0
Italy
State/province [351] 0 0
Sassari
Country [352] 0 0
Italy
State/province [352] 0 0
Torino
Country [353] 0 0
Italy
State/province [353] 0 0
Torrette Di Ancona
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Japan
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Aichi
Country [355] 0 0
Japan
State/province [355] 0 0
Bunkyo Ku
Country [356] 0 0
Japan
State/province [356] 0 0
Chiba
Country [357] 0 0
Japan
State/province [357] 0 0
Chikushino-shi
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Japan
State/province [358] 0 0
Fukuoka
Country [359] 0 0
Japan
State/province [359] 0 0
Funabashi-shi
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Japan
State/province [360] 0 0
Gifu
Country [361] 0 0
Japan
State/province [361] 0 0
Higashiibaraki-gun
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Japan
State/province [362] 0 0
Hirosaki-shi
Country [363] 0 0
Japan
State/province [363] 0 0
Hiroshima shi
Country [364] 0 0
Japan
State/province [364] 0 0
Hiroshima-shi
Country [365] 0 0
Japan
State/province [365] 0 0
Hokkaido
Country [366] 0 0
Japan
State/province [366] 0 0
Hyogo
Country [367] 0 0
Japan
State/province [367] 0 0
Isehara
Country [368] 0 0
Japan
State/province [368] 0 0
Ishikawa
Country [369] 0 0
Japan
State/province [369] 0 0
Itabashi Ku
Country [370] 0 0
Japan
State/province [370] 0 0
Kagoshima-shi
Country [371] 0 0
Japan
State/province [371] 0 0
Kasuga-shi
Country [372] 0 0
Japan
State/province [372] 0 0
Kawasaki-shi
Country [373] 0 0
Japan
State/province [373] 0 0
Kitakyushu-shi
Country [374] 0 0
Japan
State/province [374] 0 0
Kumamoto-shi
Country [375] 0 0
Japan
State/province [375] 0 0
Kumamoto
Country [376] 0 0
Japan
State/province [376] 0 0
Kusatsu-shi
Country [377] 0 0
Japan
State/province [377] 0 0
Kyoto-shi
Country [378] 0 0
Japan
State/province [378] 0 0
Matsuyama-shi
Country [379] 0 0
Japan
State/province [379] 0 0
Mito-shi
Country [380] 0 0
Japan
State/province [380] 0 0
Miyazaki-shi
Country [381] 0 0
Japan
State/province [381] 0 0
Miyazaki
Country [382] 0 0
Japan
State/province [382] 0 0
Nagoya-shi
Country [383] 0 0
Japan
State/province [383] 0 0
Narashino-shi
Country [384] 0 0
Japan
State/province [384] 0 0
Nishinomiya-shi
Country [385] 0 0
Japan
State/province [385] 0 0
Nishitokyo-shi
Country [386] 0 0
Japan
State/province [386] 0 0
Okayama-shi
Country [387] 0 0
Japan
State/province [387] 0 0
Okinawa
Country [388] 0 0
Japan
State/province [388] 0 0
Osaka Sayama shi
Country [389] 0 0
Japan
State/province [389] 0 0
Osaka-shi
Country [390] 0 0
Japan
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Osaka
Country [391] 0 0
Japan
State/province [391] 0 0
Sagamihara
Country [392] 0 0
Japan
State/province [392] 0 0
Saitama-shi
Country [393] 0 0
Japan
State/province [393] 0 0
Sapporo-shi
Country [394] 0 0
Japan
State/province [394] 0 0
Sendai shi
Country [395] 0 0
Japan
State/province [395] 0 0
Shinagawa
Country [396] 0 0
Japan
State/province [396] 0 0
Shinjuku-ku
Country [397] 0 0
Japan
State/province [397] 0 0
Suita-Shi
Country [398] 0 0
Japan
State/province [398] 0 0
Takatsuki-shi
Country [399] 0 0
Japan
State/province [399] 0 0
Tokyo
Country [400] 0 0
Japan
State/province [400] 0 0
Tomakomai
Country [401] 0 0
Japan
State/province [401] 0 0
Toyoake
Country [402] 0 0
Japan
State/province [402] 0 0
Toyota-shi
Country [403] 0 0
Japan
State/province [403] 0 0
Uwajima-shi
Country [404] 0 0
Japan
State/province [404] 0 0
Yokohama
Country [405] 0 0
Japan
State/province [405] 0 0
Yufu
Country [406] 0 0
Korea, Republic of
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Anyang-si
Country [407] 0 0
Korea, Republic of
State/province [407] 0 0
Busan
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Korea, Republic of
State/province [408] 0 0
Cheonan-si
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Korea, Republic of
State/province [409] 0 0
Cheongju-si
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Korea, Republic of
State/province [410] 0 0
Chuncheon
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Korea, Republic of
State/province [411] 0 0
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Country [412] 0 0
Korea, Republic of
State/province [412] 0 0
Daejeon
Country [413] 0 0
Korea, Republic of
State/province [413] 0 0
Goyang-si
Country [414] 0 0
Korea, Republic of
State/province [414] 0 0
Guri-Si
Country [415] 0 0
Korea, Republic of
State/province [415] 0 0
Gwangju
Country [416] 0 0
Korea, Republic of
State/province [416] 0 0
Gyeonggi-do
Country [417] 0 0
Korea, Republic of
State/province [417] 0 0
Incheon
Country [418] 0 0
Korea, Republic of
State/province [418] 0 0
Seongnam
Country [419] 0 0
Korea, Republic of
State/province [419] 0 0
Seoul
Country [420] 0 0
Korea, Republic of
State/province [420] 0 0
Suwon
Country [421] 0 0
Korea, Republic of
State/province [421] 0 0
Wonju
Country [422] 0 0
Korea, Republic of
State/province [422] 0 0
Yongin si
Country [423] 0 0
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Daugavpils
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Latvia
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Riga
Country [425] 0 0
Lithuania
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Kaunas
Country [426] 0 0
Lithuania
State/province [426] 0 0
Klaipeda
Country [427] 0 0
Lithuania
State/province [427] 0 0
Vilnius
Country [428] 0 0
Malaysia
State/province [428] 0 0
Alor Setar
Country [429] 0 0
Malaysia
State/province [429] 0 0
Kota Bharu
Country [430] 0 0
Malaysia
State/province [430] 0 0
Kota Kinabalu
Country [431] 0 0
Malaysia
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Kuala Lumpur
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Malaysia
State/province [432] 0 0
Kuantan
Country [433] 0 0
Malaysia
State/province [433] 0 0
Selayang
Country [434] 0 0
Malaysia
State/province [434] 0 0
Seri Manjung
Country [435] 0 0
Malaysia
State/province [435] 0 0
Taiping
Country [436] 0 0
Netherlands
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Alkmaar
Country [437] 0 0
Netherlands
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Almelo
Country [438] 0 0
Netherlands
State/province [438] 0 0
Amersfoort
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Netherlands
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Amsterdam
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Netherlands
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Delft
Country [441] 0 0
Netherlands
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Deventer
Country [442] 0 0
Netherlands
State/province [442] 0 0
Doetinchem
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Netherlands
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Ede
Country [444] 0 0
Netherlands
State/province [444] 0 0
Eindhoven
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Netherlands
State/province [445] 0 0
Gouda
Country [446] 0 0
Netherlands
State/province [446] 0 0
Heerlen
Country [447] 0 0
Netherlands
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Helmond
Country [448] 0 0
Netherlands
State/province [448] 0 0
Leiderdorp
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Netherlands
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Nieuwegein
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Netherlands
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Nijmegen
Country [451] 0 0
Netherlands
State/province [451] 0 0
Rotterdam
Country [452] 0 0
Netherlands
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s-Hertogenbosch
Country [453] 0 0
Netherlands
State/province [453] 0 0
Sneek
Country [454] 0 0
Netherlands
State/province [454] 0 0
Tilburg
Country [455] 0 0
Netherlands
State/province [455] 0 0
Veldhoven
Country [456] 0 0
Netherlands
State/province [456] 0 0
Zutphen
Country [457] 0 0
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Auckland
Country [458] 0 0
New Zealand
State/province [458] 0 0
Christchurch
Country [459] 0 0
New Zealand
State/province [459] 0 0
Dunedin
Country [460] 0 0
New Zealand
State/province [460] 0 0
Hamilton
Country [461] 0 0
New Zealand
State/province [461] 0 0
Hastings
Country [462] 0 0
New Zealand
State/province [462] 0 0
New Plymouth
Country [463] 0 0
New Zealand
State/province [463] 0 0
Otahuhu
Country [464] 0 0
New Zealand
State/province [464] 0 0
Rotorua
Country [465] 0 0
New Zealand
State/province [465] 0 0
Tauranga
Country [466] 0 0
Philippines
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Cebu City
Country [467] 0 0
Philippines
State/province [467] 0 0
Davao City
Country [468] 0 0
Philippines
State/province [468] 0 0
Davao
Country [469] 0 0
Philippines
State/province [469] 0 0
Iloilo
Country [470] 0 0
Philippines
State/province [470] 0 0
Lipa City
Country [471] 0 0
Philippines
State/province [471] 0 0
Maynila
Country [472] 0 0
Philippines
State/province [472] 0 0
San Fernando
Country [473] 0 0
Philippines
State/province [473] 0 0
San Juan
Country [474] 0 0
Poland
State/province [474] 0 0
Biala Podlaska
Country [475] 0 0
Poland
State/province [475] 0 0
Bydgoszcz
Country [476] 0 0
Poland
State/province [476] 0 0
Chojnice
Country [477] 0 0
Poland
State/province [477] 0 0
Chorzow
Country [478] 0 0
Poland
State/province [478] 0 0
Chrzanow
Country [479] 0 0
Poland
State/province [479] 0 0
Elblag
Country [480] 0 0
Poland
State/province [480] 0 0
Gdansk
Country [481] 0 0
Poland
State/province [481] 0 0
Gdynia
Country [482] 0 0
Poland
State/province [482] 0 0
Grodzisk Mazowiecki
Country [483] 0 0
Poland
State/province [483] 0 0
Jelenia Góra
Country [484] 0 0
Poland
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Katowice
Country [485] 0 0
Poland
State/province [485] 0 0
Kielce
Country [486] 0 0
Poland
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Krakow
Country [487] 0 0
Poland
State/province [487] 0 0
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Country [488] 0 0
Poland
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Lodz
Country [489] 0 0
Poland
State/province [489] 0 0
Lowicz
Country [490] 0 0
Poland
State/province [490] 0 0
Lublin
Country [491] 0 0
Poland
State/province [491] 0 0
Olsztyn
Country [492] 0 0
Poland
State/province [492] 0 0
Ostrowiec Swietokrzyski
Country [493] 0 0
Poland
State/province [493] 0 0
Oswiecim
Country [494] 0 0
Poland
State/province [494] 0 0
Piaseczno
Country [495] 0 0
Poland
State/province [495] 0 0
Poznan
Country [496] 0 0
Poland
State/province [496] 0 0
Przemysl
Country [497] 0 0
Poland
State/province [497] 0 0
Ruda Slaska
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State/province [498] 0 0
Rzeszow
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Poland
State/province [499] 0 0
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Poland
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Skierniewice
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Poland
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Warsaw
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Warszawa
Country [503] 0 0
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State/province [503] 0 0
Wroclaw
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Poland
State/province [504] 0 0
Zamosc
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Poland
State/province [505] 0 0
Zarow
Country [506] 0 0
Portugal
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Coimbra
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Portugal
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Covilha
Country [508] 0 0
Portugal
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Figueira da Foz
Country [509] 0 0
Portugal
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Lisboa
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Portugal
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Santa Maria da Feira
Country [511] 0 0
Portugal
State/province [511] 0 0
Torres Novas
Country [512] 0 0
Portugal
State/province [512] 0 0
Vila Nova de Gaia
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Portugal
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Vila Real
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Romania
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Braila
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Sibiu
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Romania
State/province [524] 0 0
Suceava
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Romania
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Targu Mures
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Romania
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Tg. Mures
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Romania
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Timisoara
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Serbia
State/province [528] 0 0
Belgrade
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Serbia
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Kragujevac
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Serbia
State/province [530] 0 0
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State/province [531] 0 0
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Serbia
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Presov
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Svidnik
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Centurion
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South Africa
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Pretoria
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Tongaat
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Spain
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Spain
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Spain
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Spain
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Spain
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Lleida
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Spain
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Spain
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Spain
State/province [568] 0 0
Sabadell
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Spain
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Spain
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan County
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Turkey
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Afyon
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Ankara
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Turkey
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Antalya
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kayseri
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Turkey
State/province [584] 0 0
Mersin
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Turkey
State/province [585] 0 0
Samsun
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United Kingdom
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Bristol
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Clydebank
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Dorchester
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Exeter
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High Wycombe
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United Kingdom
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Lincoln
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United Kingdom
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London
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United Kingdom
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Sheffield
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United Kingdom
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Stevenage
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United Kingdom
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Truro
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United Kingdom
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Wigan
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United Kingdom
State/province [597] 0 0
Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.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?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


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.