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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06120491
Registration number
NCT06120491
Ethics application status
Date submitted
17/10/2023
Date registered
7/11/2023
Titles & IDs
Public title
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
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Scientific title
A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)
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Secondary ID [1]
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2023-504214-30-00
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Secondary ID [2]
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D9723C00001
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Universal Trial Number (UTN)
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Trial acronym
EvoPAR-PR01
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-Sensitive Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Inflammatory and Immune System
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0
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0
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Saruparib
Treatment: Drugs - Placebo
Treatment: Drugs - Abiraterone Acetate
Treatment: Drugs - Darolutamide
Treatment: Drugs - Enzalutamide
Experimental: Arm 1: Saruparib (AZD5305) + Physician's Choice NHA - Saruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
Placebo comparator: Arm 2: Placebo + Physician's Choice NHA - Placebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
Treatment: Drugs: Saruparib
Oral
Treatment: Drugs: Placebo
Oral
Treatment: Drugs: Abiraterone Acetate
Oral
Treatment: Drugs: Darolutamide
Oral
Treatment: Drugs: Enzalutamide
Oral
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Radiographic Progression-Free Survival (rPFS)
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Assessment method [1]
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rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or, death due to any cause.
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Timepoint [1]
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up to approximately 50 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from randomisation until the date of death due to any cause.
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Timepoint [1]
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up to approximately 90 months
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Secondary outcome [2]
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Second Progression-Free Survival (PFS2)
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Assessment method [2]
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Time from randomisation to PFS2 is defined as the time from randomisation to the earliest of progression (defined as radiographic progression, clinical progression, or PSA progression) after initiation of first subsequent treatment following the initial investigator-assessed progression or death.
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Timepoint [2]
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up to approximately 90 months
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Secondary outcome [3]
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Time to First Subsequent Therapy or Death (TFST)
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Assessment method [3]
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TFST is defined as the time from randomisation to the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause.
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Timepoint [3]
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up to approximately 90 months
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Secondary outcome [4]
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Symptomatic Skeletal Event-Free Survival (SSE-FS)
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Assessment method [4]
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SSE-FS is defined as the time from randomisation to the earliest of the following:
* Use of radiation therapy to prevent or relieve skeletal symptoms.
* Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral).
* Occurrence of spinal cord compression.
* Orthopaedic surgical intervention for bone metastasis.
* Death due to any cause.
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Timepoint [4]
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up to approximately 90 months
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Secondary outcome [5]
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Time to the First Castration-Resistant Event (TTCR)
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Assessment method [5]
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TTCR is defined as the time from randomisation to the first castration resistant event (radiographic disease progression per RECIST 1.1 \[soft tissue\] and/or PCWG3 criteria \[bone\], PSA progression per PCWG3, or SSE, PSA progression per PCWG3, or SSE), whichever occurs first, with castrate levels of testosterone (below 50 ng/dL).
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Timepoint [5]
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up to approximately 90 months
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Secondary outcome [6]
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Time to Pain Progression (TTPP)
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Assessment method [6]
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TTPP is defined as the time from randomisation to clinically meaningful pain progression based on a 2-point increase from baseline in the Brief Pain Inventory - Short Form (BPI-SF) Item 3 'worst pain in 24 hours' score and/or initiation of/increase in opioid analgesic use.
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Timepoint [6]
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up to approximately 90 months
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Secondary outcome [7]
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Time To Deterioration in Urinary Symptoms (TTDUS)
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Assessment method [7]
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TTDUS is defined as the time from randomisation to deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Prostate Questionnaire (Urinary Symptoms) (QLQPR25 \[US\]) subscale scores.
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Timepoint [7]
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up to approximately 90 months
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Secondary outcome [8]
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Time to Deterioration in Fatigue (TTDF)
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Assessment method [8]
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TTDF is defined as the time from randomisation to deterioration in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7A scores.
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Timepoint [8]
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up to approximately 90 months
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Secondary outcome [9]
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Time to Deterioration in Physical Function (TTDPF)
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Assessment method [9]
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TTDPF is defined as the time from randomisation to deterioration in PROMIS Physical Function Short Form 8C scores.
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Timepoint [9]
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up to approximately 90 months
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Secondary outcome [10]
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Health-related Quality of Life (HrQoL)
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Assessment method [10]
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Change from baseline in BPI-SF worst pain score, pain severity, and interference domain scores.
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Timepoint [10]
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up to approximately 90 months
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Secondary outcome [11]
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BRCA and other HRR gene mutation status.
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Assessment method [11]
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Timepoint [11]
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at screening
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Secondary outcome [12]
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Plasma concentrations of AZD5305
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Assessment method [12]
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Timepoint [12]
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up to approximately 90 months
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Secondary outcome [13]
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Samples will be used to develop complementary or companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study.
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Assessment method [13]
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Samples will be tested by a CDx to certify consistency with assays used in the study.
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Timepoint [13]
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up to approximately 90 months
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Secondary outcome [14]
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PSA (prostate-specific antigen) undetectable rate at 6, 12 months
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Assessment method [14]
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proportion of participants with undetectable PSA (\< 0.2 ng/mL) for those with PSA = 0.2 ng/mL at baseline
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Timepoint [14]
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up to approximately 90 months
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Eligibility
Key inclusion criteria
* Male = 18 years of age
* Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.
* Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of = 1 bone lesion and/or = 1 soft tissue lesion that is suitable for repeated assessment with CT and/or MRI.
* Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting = 14 days and < 4 months prior to randomisation
* ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.
* Provision of FFPE tumour tissue sample and blood sample (for ctDNA)
* Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to
determine cohort eligibility
* Adequate organ and bone marrow function as described in study protocol
* Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
* Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Participants with a history of MDS/AML or with features suggestive of MDS/AML
* Participants with any known predisposition to bleeding
* Any history of persisting (> 2 weeks) severe cytopenia
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.
* History of another primary malignancy, with exceptions
* Persistent toxicities (CTCAE Grade = 2) caused by previous anticancer therapy.
* Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention
* Cardiac criteria, including history of arrythmia and cardiovascular disease
* Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions:
* Prior treatment within 14 days with blood product support or growth factor support.
* Participants who are unevaluable for both bone and soft tissue progression
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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
21/11/2023
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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
30/04/2031
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Actual
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Sample size
Target
1800
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Chermside
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Research Site - Darlinghurst
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Research Site - Hyde Park
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Research Site - Kurralta Park
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Research Site - Melbourne
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Research Site - Randwick
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Recruitment hospital [7]
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Research Site - South Brisbane
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Recruitment postcode(s) [1]
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4032 - Chermside
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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4812 - Hyde Park
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Recruitment postcode(s) [4]
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5037 - Kurralta Park
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Recruitment postcode(s) [5]
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3000 - Melbourne
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Recruitment postcode(s) [6]
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2031 - Randwick
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Recruitment postcode(s) [7]
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4101 - South Brisbane
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Recruitment outside Australia
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Finland
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State/province [95]
0
0
Helsinki
Query!
Country [96]
0
0
Finland
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State/province [96]
0
0
Tampere
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Country [97]
0
0
Finland
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State/province [97]
0
0
Turku
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Country [98]
0
0
France
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State/province [98]
0
0
Angers
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Country [99]
0
0
France
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State/province [99]
0
0
Aurillac Cedex
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Country [100]
0
0
France
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State/province [100]
0
0
Bayonne
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Country [101]
0
0
France
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State/province [101]
0
0
Bordeaux Cedex
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Country [102]
0
0
France
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State/province [102]
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Caen Cedex 5
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Country [103]
0
0
France
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State/province [103]
0
0
Clermont Ferrand
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Country [104]
0
0
France
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State/province [104]
0
0
Lyon
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Country [105]
0
0
France
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State/province [105]
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0
Montpellier
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Country [106]
0
0
France
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State/province [106]
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Nice
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Country [107]
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0
France
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State/province [107]
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Nimes
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Country [108]
0
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France
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State/province [108]
0
0
Pierre Bénite
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Country [109]
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0
France
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State/province [109]
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0
Poitiers Cedex
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Country [110]
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France
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State/province [110]
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0
Quimper Cedex
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Country [111]
0
0
France
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State/province [111]
0
0
Rennes Cedex 9
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Country [112]
0
0
France
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State/province [112]
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Strasbourg
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Country [113]
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0
France
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State/province [113]
0
0
Tours
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Country [114]
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France
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State/province [114]
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0
Vandoeuvre les Nancy
Query!
Country [115]
0
0
Germany
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State/province [115]
0
0
Bergisch Gladbach
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Country [116]
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0
Germany
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State/province [116]
0
0
Berlin
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Germany
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Bonn
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Germany
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0
Braunschweig
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Germany
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Dresden
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Germany
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Duisburg
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Germany
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Erlangen
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Germany
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Frankfurt am Main
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0
Germany
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Frankfurt
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Germany
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Freiburg
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0
Germany
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Göttingen
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0
Germany
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0
Hamburg
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0
Germany
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0
Heidelberg
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Germany
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Herne
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Germany
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Homburg
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Germany
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Köln
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0
Germany
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Magdeburg
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Germany
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Mannheim
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Germany
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Marburg
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Germany
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Mettmann
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Germany
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München
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0
Germany
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Münster
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0
0
Germany
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State/province [137]
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0
Nürtingen
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Germany
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Oldenburg
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0
Germany
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Regensburg
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0
Germany
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Stuttgart
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Germany
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Trier
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Germany
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Tübingen
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0
Germany
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Ulm
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0
Hungary
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Budapest
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0
Hungary
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State/province [145]
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0
Debrecen
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Country [146]
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0
Hungary
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State/province [146]
0
0
Gyor
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0
Hungary
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State/province [147]
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0
Miskolc
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Country [148]
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0
Hungary
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State/province [148]
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Nyíregyháza
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0
Hungary
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State/province [149]
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0
Szekszárd
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Country [150]
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0
India
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State/province [150]
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0
Bangalore
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Country [151]
0
0
India
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State/province [151]
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Calicut
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0
0
India
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State/province [152]
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Delhi
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0
0
India
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0
Hyderabad
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0
0
India
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State/province [154]
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JAipur
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0
0
India
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State/province [155]
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0
Kolkata
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0
0
India
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State/province [156]
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0
Lucknow
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0
0
India
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State/province [157]
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0
Mohali
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0
0
India
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State/province [158]
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0
Nagpur
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0
0
India
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0
New Delhi
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0
0
India
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State/province [160]
0
0
Pune
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0
0
India
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0
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Surat
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0
0
India
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Vadodara
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0
0
India
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State/province [163]
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Varanasi
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Country [164]
0
0
Italy
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0
0
Bari
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Country [165]
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0
Italy
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State/province [165]
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0
Genoa
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Country [166]
0
0
Italy
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State/province [166]
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0
Meldola
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Country [167]
0
0
Italy
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State/province [167]
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Milano
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Country [168]
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0
Italy
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State/province [168]
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0
Napoli
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0
0
Italy
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Padova
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0
0
Italy
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Rome
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0
0
Italy
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State/province [171]
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Rozzano
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Country [172]
0
0
Italy
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State/province [172]
0
0
Terni
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0
0
Italy
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State/province [173]
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Trento
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0
Japan
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State/province [174]
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0
Chiba-shi
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0
Japan
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State/province [175]
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0
Fukuoka-shi
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0
Japan
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State/province [176]
0
0
Fukuoka
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Country [177]
0
0
Japan
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State/province [177]
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0
Hirakata-shi
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0
Japan
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Hirosaki-shi
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Japan
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Kanazawa-shi
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Japan
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0
Kashihara-shi
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Japan
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0
Kawagoe-shi
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0
0
Japan
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State/province [182]
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0
Kisarazu-shi
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Country [183]
0
0
Japan
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State/province [183]
0
0
Kita-gun
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0
0
Japan
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State/province [184]
0
0
Kobe-shi
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Country [185]
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0
Japan
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State/province [185]
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0
Kumamoto-shi
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0
0
Japan
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State/province [186]
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0
Maebashi-shi
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0
0
Japan
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State/province [187]
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0
Nagano-shi
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0
Japan
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State/province [188]
0
0
Nagasaki-shi
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0
Japan
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State/province [189]
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0
Nagoya-shi
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Country [190]
0
0
Japan
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State/province [190]
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0
Nagoya
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0
0
Japan
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State/province [191]
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0
Osaka-shi
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Country [192]
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0
Japan
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State/province [192]
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0
Osakasayama-shi
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Country [193]
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0
Japan
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State/province [193]
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0
Sagamihara-shi
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Country [194]
0
0
Japan
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State/province [194]
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0
Sakura-shi
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Country [195]
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0
Japan
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State/province [195]
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0
Sapporo-shi
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Country [196]
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0
Japan
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State/province [196]
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0
Shiwa-gun
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Country [197]
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0
Japan
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State/province [197]
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0
Suita-shi
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Country [198]
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Japan
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State/province [198]
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Tsu-shi
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0
Japan
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State/province [199]
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0
Yokohama-shi
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Japan
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State/province [200]
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0
Yufu-shi
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Country [201]
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0
Korea, Republic of
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0
Daejeon
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0
Korea, Republic of
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State/province [202]
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0
Seongnam-si
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0
Korea, Republic of
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0
Seoul
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0
Korea, Republic of
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State/province [204]
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Suwon
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Country [205]
0
0
Malaysia
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State/province [205]
0
0
George Town
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Country [206]
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0
Malaysia
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State/province [206]
0
0
Johor Bahru
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0
Malaysia
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State/province [207]
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0
Kota Kinabalu
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Country [208]
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Malaysia
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State/province [208]
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0
Kuala Lumpur
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0
Malaysia
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State/province [209]
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0
Kuching
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Country [210]
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0
Netherlands
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State/province [210]
0
0
Amsterdam
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0
Netherlands
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0
Hilversum
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0
Netherlands
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Nijmegen
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0
0
Peru
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State/province [213]
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0
Arequipa
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0
Peru
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State/province [214]
0
0
Lima
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Country [215]
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0
Poland
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State/province [215]
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0
Bydgoszcz
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0
Poland
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State/province [216]
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Koszalin
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0
Poland
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Poznan
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Poland
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0
Rzeszów
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Poland
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Szczecin
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Poland
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Warszawa
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Poland
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Wroclaw
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Poland
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Zory
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0
Spain
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Barcelona
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0
Spain
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0
Córdoba
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0
Spain
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State/province [225]
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0
L'Hospitalet de Llobregat
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0
Spain
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Lugo
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0
Spain
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Madrid
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0
Spain
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Sabadell
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Spain
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Valencia
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Sweden
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0
Göteborg
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0
Sweden
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Malmo
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0
Sweden
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0
Solna
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0
Sweden
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Stockholm
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0
Taiwan
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0
Kaohsiung city
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0
0
Taiwan
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0
Kaohsiung
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0
0
Taiwan
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Taichung
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0
0
Taiwan
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Taoyuan
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0
Taiwan
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0
0
Yung Kang City
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0
0
Thailand
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0
0
Bangkok
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Country [240]
0
0
Thailand
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0
0
Chiang Mai
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Country [241]
0
0
Thailand
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0
0
Khlong Luang
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Country [242]
0
0
Thailand
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0
0
Songkla
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Country [243]
0
0
Turkey
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0
0
Ankara
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Country [244]
0
0
Turkey
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0
Bornova-Izmir
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0
Turkey
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0
Fatih-Istanbul
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0
0
Turkey
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0
Istanbul
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0
0
Turkey
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0
Karsiyaka
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0
0
United Kingdom
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Aberdeen
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0
0
United Kingdom
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0
0
Birmingham
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0
0
United Kingdom
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Cambridge
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0
0
United Kingdom
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Glasgow
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0
0
United Kingdom
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Guildford
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0
0
United Kingdom
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0
London
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0
0
United Kingdom
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0
Manchester
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Country [255]
0
0
United Kingdom
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0
0
Newcastle upon Tyne
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0
0
United Kingdom
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0
0
Oxford
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0
0
United Kingdom
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0
0
Plymouth
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Country [258]
0
0
United Kingdom
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0
0
Preston
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Country [259]
0
0
United Kingdom
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0
0
Swansea
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Country [260]
0
0
United Kingdom
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State/province [260]
0
0
Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06120491
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Kim Nguyen Chi, MD
Query!
Address
0
0
BC Cancer, Canada
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
AstraZeneca Clinical Study Information Center
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-877-240-9479
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Query!
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Query!
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/NCT06120491