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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05774951
Registration number
NCT05774951
Ethics application status
Date submitted
16/02/2023
Date registered
20/03/2023
Date last updated
19/04/2024
Titles & IDs
Public title
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
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Scientific title
A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer
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Secondary ID [1]
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2022-501024-20-00
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Secondary ID [2]
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D8531C00002
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Universal Trial Number (UTN)
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Trial acronym
CAMBRIA-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer, Early Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Camizestrant
Treatment: Drugs - Tamoxifen
Treatment: Drugs - Anastrozole
Treatment: Drugs - Letrozole
Treatment: Drugs - Exemestane
Active Comparator: Arm A: standard endocrine therapy of investigator´s choice - Continue standard endocrine therapy of investigator's choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen)
Experimental: Arm B: camizestrant - Camizestrant
Treatment: Drugs: Camizestrant
Camizestrant. Experimental. Administered orally
Treatment: Drugs: Tamoxifen
Tamoxifen. Comparator. Administered per local approved label
Treatment: Drugs: Anastrozole
Anastrozole. Comparator. Administered per local approved label
Treatment: Drugs: Letrozole
Letrozole. Comparator. Administered per local approved label
Treatment: Drugs: Exemestane
Exemestane. Comparator. Administered per local approved label
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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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Invasive breast cancer-free survival (IBCFS)
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Assessment method [1]
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IBCFS is defined as time from randomisation until date of first occurrence of:
Invasive ipsilateral breast tumour recurrence (invasive IBTR)
Locoregional invasive breast cancer recurrence
Distant recurrence
Invasive contralateral breast cancer
Death attributable to any cause.
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Timepoint [1]
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Up to 10 years
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Secondary outcome [1]
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Invasive disease-free survival (IDFS)
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Assessment method [1]
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IDFS is defined as time from randomisation until date of first occurrence of one of the following events:
Invasive ipsilateral breast tumor recurrence (invasive IBTR)
Locoregional invasive breast cancer recurrence
Distant recurrence
Invasive contralateral breast cancer
Second primary non-breast invasive cancer
Death attributable to any cause.
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Timepoint [1]
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Up to 10 years
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Secondary outcome [2]
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Distant relapse-free survival (DRFS)
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Assessment method [2]
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DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first.
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Timepoint [2]
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Up to 10 years
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Secondary outcome [3]
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Overall survival (OS)
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Assessment method [3]
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OS is defined as time from randomisation until death from any cause.
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Timepoint [3]
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Up to 10 years
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Secondary outcome [4]
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Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)
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Assessment method [4]
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Timepoint [4]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [5]
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Absolute and percent change from baseline in Clinical Laboratory Parameters
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Assessment method [5]
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Timepoint [5]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [6]
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Absolute and percent change from baseline in Vital Sign Parameters
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Assessment method [6]
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Timepoint [6]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [7]
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Number of participants with abnormal physical examinations
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Assessment method [7]
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Timepoint [7]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [8]
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Change from baseline of arthralgia as measured by the EORTC-IL-194 (European Organisation for Research and Treatment of Cancer) item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
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Assessment method [8]
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0
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Timepoint [8]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [9]
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Change from baseline of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
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Assessment method [9]
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0
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Timepoint [9]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [10]
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Change from baseline of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
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Assessment method [10]
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Timepoint [10]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [11]
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Proportion of patients experiencing each level of symptomatic AEs of arthralgia as measured by the EORTC-IL-194 item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
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Assessment method [11]
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0
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Timepoint [11]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [12]
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Proportion of patients experiencing each level of symptomatic AEs of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
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Assessment method [12]
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0
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Timepoint [12]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [13]
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Proportion of patients experiencing each level of symptomatic AEs of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
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Assessment method [13]
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Timepoint [13]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [14]
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Change from baseline and TTD (time to deterioration ) of health-related QoL (quality of life) as measured by the 2 global QoL items from the EORTC-QLQ-C30 items 11 and 12. EORTC-QLQ-C30 uses 0 - 4 scale (higher score is worse)
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Assessment method [14]
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Timepoint [14]
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Until 28 days after the final dose of study treatment (up to 5 years)
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Secondary outcome [15]
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Pharmacokinetics (PK)
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Assessment method [15]
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• Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration)
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Timepoint [15]
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Until 6 months from treatment start
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Eligibility
Key inclusion criteria
- Women and Men, =18 years at the time of screening (or per national guidelines)
- Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with
high or intermediate risk of recurrence, based on clinical-pathological risk features,
as defined in the protocol.
- Completed adequate (definitive) locoregional therapy (surgery with or without
radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant
chemotherapy
- Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/-
CDK4/6 inhibitor)
- Eastern Cooperative Oncology Group (ECOG) performance status of = 1
- Adequate organ and marrow function
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Minimum age
18
Years
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Maximum age
130
Years
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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:
- Inoperable locally advanced or metastatic breast cancer
- Pathological complete response following treatment with neoadjuvant therapy
- History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of
the cervix or considered at very low risk of recurrence per investigator judgement)
unless in complete remission with no therapy for a minimum of 5 years from the date of
randomisation
- Any evidence of severe or uncontrolled systemic diseases which, in the investigator's
opinion precludes participation in the study or compliance
- Known LVEF <50% with heart failure NYHA Grade =2.
- Mean resting QTcF interval >480 ms at screening
- Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for
non-cancer-related conditions
- Any concurrent anti-cancer treatment not specified in the protocol with the exception
of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab)
- Previous treatment with camizestrant, investigational SERDs/investigational ER
targeting agents, or fulvestrant
- Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding
- Patients with known hypersensitivity to active or inactive excipients of camizestrant
or drugs with a similar chemical structure or class to camizestrant. In
pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance
to LHRH agonists, that would preclude the patient from receiving any LHRH agonist
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
31/03/2023
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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
29/05/2036
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Actual
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Sample size
Target
4300
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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 - Birtinya
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Recruitment hospital [2]
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Research Site - Brighton
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Recruitment hospital [3]
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Research Site - Concord
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Recruitment hospital [4]
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Research Site - Nedlands
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Recruitment hospital [5]
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Research Site - Randwick
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Recruitment hospital [6]
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Research Site - Tweed Heads
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Recruitment hospital [7]
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Research Site - Waratah
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Recruitment hospital [8]
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Research Site - Wendouree
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Recruitment postcode(s) [1]
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4575 - Birtinya
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Recruitment postcode(s) [2]
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3186 - Brighton
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Recruitment postcode(s) [3]
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2139 - Concord
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment postcode(s) [5]
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2031 - Randwick
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Recruitment postcode(s) [6]
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2485 - Tweed Heads
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Recruitment postcode(s) [7]
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2298 - Waratah
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Recruitment postcode(s) [8]
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3355 - Wendouree
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Alaska
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maine
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Massachusetts
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New Hampshire
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West Virginia
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Ciudad Autónoma Buenos Aires
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Cordoba
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Salta
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San Miguel de Tucumán
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Graz
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Steyr
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Niterói
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Recife
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Brazil
Query!
State/province [94]
0
0
Rio De Janeiro
Query!
Country [95]
0
0
Brazil
Query!
State/province [95]
0
0
Salvador
Query!
Country [96]
0
0
Brazil
Query!
State/province [96]
0
0
Sao Paulo
Query!
Country [97]
0
0
Brazil
Query!
State/province [97]
0
0
São Paulo
Query!
Country [98]
0
0
Brazil
Query!
State/province [98]
0
0
Taubaté
Query!
Country [99]
0
0
Brazil
Query!
State/province [99]
0
0
Tres Lagoas
Query!
Country [100]
0
0
Brazil
Query!
State/province [100]
0
0
Vitória
Query!
Country [101]
0
0
Bulgaria
Query!
State/province [101]
0
0
Dobrich
Query!
Country [102]
0
0
Bulgaria
Query!
State/province [102]
0
0
Plovdiv
Query!
Country [103]
0
0
Bulgaria
Query!
State/province [103]
0
0
Sofia
Query!
Country [104]
0
0
Bulgaria
Query!
State/province [104]
0
0
Vratsa
Query!
Country [105]
0
0
Canada
Query!
State/province [105]
0
0
Alberta
Query!
Country [106]
0
0
Canada
Query!
State/province [106]
0
0
British Columbia
Query!
Country [107]
0
0
Canada
Query!
State/province [107]
0
0
Manitoba
Query!
Country [108]
0
0
Canada
Query!
State/province [108]
0
0
Ontario
Query!
Country [109]
0
0
Canada
Query!
State/province [109]
0
0
Quebec
Query!
Country [110]
0
0
Chile
Query!
State/province [110]
0
0
Concepcion
Query!
Country [111]
0
0
Chile
Query!
State/province [111]
0
0
La Serena
Query!
Country [112]
0
0
Chile
Query!
State/province [112]
0
0
Puerto Montt
Query!
Country [113]
0
0
Chile
Query!
State/province [113]
0
0
Santiago
Query!
Country [114]
0
0
Chile
Query!
State/province [114]
0
0
Talca
Query!
Country [115]
0
0
Chile
Query!
State/province [115]
0
0
Temuco
Query!
Country [116]
0
0
Chile
Query!
State/province [116]
0
0
Vina del Mar
Query!
Country [117]
0
0
China
Query!
State/province [117]
0
0
Baoding
Query!
Country [118]
0
0
China
Query!
State/province [118]
0
0
Beijing
Query!
Country [119]
0
0
China
Query!
State/province [119]
0
0
Changchun
Query!
Country [120]
0
0
China
Query!
State/province [120]
0
0
Changsha
Query!
Country [121]
0
0
China
Query!
State/province [121]
0
0
Chengdu
Query!
Country [122]
0
0
China
Query!
State/province [122]
0
0
Chifeng
Query!
Country [123]
0
0
China
Query!
State/province [123]
0
0
Dalian
Query!
Country [124]
0
0
China
Query!
State/province [124]
0
0
Foshan
Query!
Country [125]
0
0
China
Query!
State/province [125]
0
0
Fuzhou
Query!
Country [126]
0
0
China
Query!
State/province [126]
0
0
Guangzhou Shi
Query!
Country [127]
0
0
China
Query!
State/province [127]
0
0
Guangzhou
Query!
Country [128]
0
0
China
Query!
State/province [128]
0
0
Haikou
Query!
Country [129]
0
0
China
Query!
State/province [129]
0
0
Hangzhou
Query!
Country [130]
0
0
China
Query!
State/province [130]
0
0
Harbin
Query!
Country [131]
0
0
China
Query!
State/province [131]
0
0
Hefei
Query!
Country [132]
0
0
China
Query!
State/province [132]
0
0
Hohhot
Query!
Country [133]
0
0
China
Query!
State/province [133]
0
0
Huangpu District
Query!
Country [134]
0
0
China
Query!
State/province [134]
0
0
Ji Nan
Query!
Country [135]
0
0
China
Query!
State/province [135]
0
0
Lanzhou
Query!
Country [136]
0
0
China
Query!
State/province [136]
0
0
Liuzhou
Query!
Country [137]
0
0
China
Query!
State/province [137]
0
0
Nanchang
Query!
Country [138]
0
0
China
Query!
State/province [138]
0
0
Nanjing
Query!
Country [139]
0
0
China
Query!
State/province [139]
0
0
Nanning
Query!
Country [140]
0
0
China
Query!
State/province [140]
0
0
Neijiang
Query!
Country [141]
0
0
China
Query!
State/province [141]
0
0
Qingdao
Query!
Country [142]
0
0
China
Query!
State/province [142]
0
0
Shanghai
Query!
Country [143]
0
0
China
Query!
State/province [143]
0
0
Shantou
Query!
Country [144]
0
0
China
Query!
State/province [144]
0
0
Shaoguan
Query!
Country [145]
0
0
China
Query!
State/province [145]
0
0
Shenyang
Query!
Country [146]
0
0
China
Query!
State/province [146]
0
0
Shijiazhuang
Query!
Country [147]
0
0
China
Query!
State/province [147]
0
0
Suining
Query!
Country [148]
0
0
China
Query!
State/province [148]
0
0
Suzhou
Query!
Country [149]
0
0
China
Query!
State/province [149]
0
0
Taiyuan
Query!
Country [150]
0
0
China
Query!
State/province [150]
0
0
Taizhou
Query!
Country [151]
0
0
China
Query!
State/province [151]
0
0
Tianjin
Query!
Country [152]
0
0
China
Query!
State/province [152]
0
0
WeiFang
Query!
Country [153]
0
0
China
Query!
State/province [153]
0
0
Wuhan
Query!
Country [154]
0
0
China
Query!
State/province [154]
0
0
Xiangfan
Query!
Country [155]
0
0
China
Query!
State/province [155]
0
0
Xining
Query!
Country [156]
0
0
China
Query!
State/province [156]
0
0
Xinxiang
Query!
Country [157]
0
0
China
Query!
State/province [157]
0
0
Xuzhou
Query!
Country [158]
0
0
China
Query!
State/province [158]
0
0
Yanji
Query!
Country [159]
0
0
China
Query!
State/province [159]
0
0
Yantai
Query!
Country [160]
0
0
China
Query!
State/province [160]
0
0
Zhengzhou
Query!
Country [161]
0
0
Colombia
Query!
State/province [161]
0
0
Barranquilla
Query!
Country [162]
0
0
Colombia
Query!
State/province [162]
0
0
Bogota
Query!
Country [163]
0
0
Colombia
Query!
State/province [163]
0
0
Cali
Query!
Country [164]
0
0
Colombia
Query!
State/province [164]
0
0
Floridablanca
Query!
Country [165]
0
0
Colombia
Query!
State/province [165]
0
0
Medellin
Query!
Country [166]
0
0
Colombia
Query!
State/province [166]
0
0
Monteria
Query!
Country [167]
0
0
Colombia
Query!
State/province [167]
0
0
Pereira
Query!
Country [168]
0
0
Colombia
Query!
State/province [168]
0
0
Valledupar
Query!
Country [169]
0
0
Czechia
Query!
State/province [169]
0
0
Horovice
Query!
Country [170]
0
0
Czechia
Query!
State/province [170]
0
0
Pardubice
Query!
Country [171]
0
0
Czechia
Query!
State/province [171]
0
0
Pragues
Query!
Country [172]
0
0
Czechia
Query!
State/province [172]
0
0
Praha 4
Query!
Country [173]
0
0
Czechia
Query!
State/province [173]
0
0
Praha
Query!
Country [174]
0
0
Czechia
Query!
State/province [174]
0
0
Pribram
Query!
Country [175]
0
0
France
Query!
State/province [175]
0
0
Angers Cedex 01
Query!
Country [176]
0
0
France
Query!
State/province [176]
0
0
Argenteuil
Query!
Country [177]
0
0
France
Query!
State/province [177]
0
0
Avignon
Query!
Country [178]
0
0
France
Query!
State/province [178]
0
0
Bordeaux Cedex
Query!
Country [179]
0
0
France
Query!
State/province [179]
0
0
Bordeaux Cédex
Query!
Country [180]
0
0
France
Query!
State/province [180]
0
0
Bourg en Bresse
Query!
Country [181]
0
0
France
Query!
State/province [181]
0
0
Caen cedex 05
Query!
Country [182]
0
0
France
Query!
State/province [182]
0
0
Cholet
Query!
Country [183]
0
0
France
Query!
State/province [183]
0
0
Clermont Ferrand
Query!
Country [184]
0
0
France
Query!
State/province [184]
0
0
Dijon
Query!
Country [185]
0
0
France
Query!
State/province [185]
0
0
Epagny Metz-Tessy
Query!
Country [186]
0
0
France
Query!
State/province [186]
0
0
Lille
Query!
Country [187]
0
0
France
Query!
State/province [187]
0
0
Lorient cedex
Query!
Country [188]
0
0
France
Query!
State/province [188]
0
0
Lyon
Query!
Country [189]
0
0
France
Query!
State/province [189]
0
0
Marseille
Query!
Country [190]
0
0
France
Query!
State/province [190]
0
0
Metz Cedex 03
Query!
Country [191]
0
0
France
Query!
State/province [191]
0
0
Montpellier
Query!
Country [192]
0
0
France
Query!
State/province [192]
0
0
Nantes
Query!
Country [193]
0
0
France
Query!
State/province [193]
0
0
Nimes
Query!
Country [194]
0
0
France
Query!
State/province [194]
0
0
Paris
Query!
Country [195]
0
0
France
Query!
State/province [195]
0
0
Pierre Benite
Query!
Country [196]
0
0
France
Query!
State/province [196]
0
0
Plerin SUR MER
Query!
Country [197]
0
0
France
Query!
State/province [197]
0
0
Poitiers
Query!
Country [198]
0
0
France
Query!
State/province [198]
0
0
Quimper Cedex
Query!
Country [199]
0
0
France
Query!
State/province [199]
0
0
Rennes
Query!
Country [200]
0
0
France
Query!
State/province [200]
0
0
Saint Cloud
Query!
Country [201]
0
0
France
Query!
State/province [201]
0
0
Saint Herblain Cedex
Query!
Country [202]
0
0
France
Query!
State/province [202]
0
0
Suresnes Cedex
Query!
Country [203]
0
0
France
Query!
State/province [203]
0
0
Toulouse Cedex 09
Query!
Country [204]
0
0
France
Query!
State/province [204]
0
0
Tours CEDEX
Query!
Country [205]
0
0
France
Query!
State/province [205]
0
0
Villejuif Cedex
Query!
Country [206]
0
0
France
Query!
State/province [206]
0
0
Villejuif
Query!
Country [207]
0
0
Georgia
Query!
State/province [207]
0
0
Batumi
Query!
Country [208]
0
0
Georgia
Query!
State/province [208]
0
0
Tbilisi
Query!
Country [209]
0
0
Germany
Query!
State/province [209]
0
0
Aachen
Query!
Country [210]
0
0
Germany
Query!
State/province [210]
0
0
Augsburg
Query!
Country [211]
0
0
Germany
Query!
State/province [211]
0
0
Bayreuth
Query!
Country [212]
0
0
Germany
Query!
State/province [212]
0
0
Berlin
Query!
Country [213]
0
0
Germany
Query!
State/province [213]
0
0
Bonn
Query!
Country [214]
0
0
Germany
Query!
State/province [214]
0
0
Deggendorf
Query!
Country [215]
0
0
Germany
Query!
State/province [215]
0
0
Dessau-Rosslau
Query!
Country [216]
0
0
Germany
Query!
State/province [216]
0
0
Dresden
Query!
Country [217]
0
0
Germany
Query!
State/province [217]
0
0
Düsseldorf
Query!
Country [218]
0
0
Germany
Query!
State/province [218]
0
0
Eggenfelden
Query!
Country [219]
0
0
Germany
Query!
State/province [219]
0
0
Esslingen
Query!
Country [220]
0
0
Germany
Query!
State/province [220]
0
0
Georgsmarienhuette
Query!
Country [221]
0
0
Germany
Query!
State/province [221]
0
0
Guetersloh
Query!
Country [222]
0
0
Germany
Query!
State/province [222]
0
0
Hamburg
Query!
Country [223]
0
0
Germany
Query!
State/province [223]
0
0
Heidelberg
Query!
Country [224]
0
0
Germany
Query!
State/province [224]
0
0
Kiel
Query!
Country [225]
0
0
Germany
Query!
State/province [225]
0
0
Landshut
Query!
Country [226]
0
0
Germany
Query!
State/province [226]
0
0
Luebeck
Query!
Country [227]
0
0
Germany
Query!
State/province [227]
0
0
Mainz
Query!
Country [228]
0
0
Germany
Query!
State/province [228]
0
0
Memmingen
Query!
Country [229]
0
0
Germany
Query!
State/province [229]
0
0
München
Query!
Country [230]
0
0
Germany
Query!
State/province [230]
0
0
Ravensburg
Query!
Country [231]
0
0
Germany
Query!
State/province [231]
0
0
Rüsselsheim am Main
Query!
Country [232]
0
0
Germany
Query!
State/province [232]
0
0
Stralsund
Query!
Country [233]
0
0
Germany
Query!
State/province [233]
0
0
Torgau
Query!
Country [234]
0
0
Germany
Query!
State/province [234]
0
0
Trier
Query!
Country [235]
0
0
Germany
Query!
State/province [235]
0
0
Ulm
Query!
Country [236]
0
0
Germany
Query!
State/province [236]
0
0
Velbert
Query!
Country [237]
0
0
Germany
Query!
State/province [237]
0
0
Wiesbaden
Query!
Country [238]
0
0
Germany
Query!
State/province [238]
0
0
Worms
Query!
Country [239]
0
0
Germany
Query!
State/province [239]
0
0
Wuppertal
Query!
Country [240]
0
0
Greece
Query!
State/province [240]
0
0
Athens
Query!
Country [241]
0
0
Greece
Query!
State/province [241]
0
0
Chaidari
Query!
Country [242]
0
0
Greece
Query!
State/province [242]
0
0
Heraklion
Query!
Country [243]
0
0
Greece
Query!
State/province [243]
0
0
Ioannina
Query!
Country [244]
0
0
Greece
Query!
State/province [244]
0
0
Rio
Query!
Country [245]
0
0
Greece
Query!
State/province [245]
0
0
Thessaloniki
Query!
Country [246]
0
0
Hungary
Query!
State/province [246]
0
0
Budapest
Query!
Country [247]
0
0
Hungary
Query!
State/province [247]
0
0
Debrecen
Query!
Country [248]
0
0
Hungary
Query!
State/province [248]
0
0
Gyula
Query!
Country [249]
0
0
Hungary
Query!
State/province [249]
0
0
Gyor
Query!
Country [250]
0
0
Hungary
Query!
State/province [250]
0
0
Kaposvár
Query!
Country [251]
0
0
Hungary
Query!
State/province [251]
0
0
Miskolc
Query!
Country [252]
0
0
Hungary
Query!
State/province [252]
0
0
Nyíregyháza
Query!
Country [253]
0
0
Hungary
Query!
State/province [253]
0
0
Szekszárd
Query!
Country [254]
0
0
Hungary
Query!
State/province [254]
0
0
Szolnok
Query!
Country [255]
0
0
India
Query!
State/province [255]
0
0
Bangalore
Query!
Country [256]
0
0
India
Query!
State/province [256]
0
0
Belagavi
Query!
Country [257]
0
0
India
Query!
State/province [257]
0
0
Bhubaneswar
Query!
Country [258]
0
0
India
Query!
State/province [258]
0
0
Hubli
Query!
Country [259]
0
0
India
Query!
State/province [259]
0
0
Hyderabad
Query!
Country [260]
0
0
India
Query!
State/province [260]
0
0
Jaipur
Query!
Country [261]
0
0
India
Query!
State/province [261]
0
0
Kolkata
Query!
Country [262]
0
0
India
Query!
State/province [262]
0
0
Mumbai
Query!
Country [263]
0
0
India
Query!
State/province [263]
0
0
Nagpur
Query!
Country [264]
0
0
India
Query!
State/province [264]
0
0
Nashik
Query!
Country [265]
0
0
India
Query!
State/province [265]
0
0
New Delhi
Query!
Country [266]
0
0
India
Query!
State/province [266]
0
0
Pune
Query!
Country [267]
0
0
India
Query!
State/province [267]
0
0
Thane
Query!
Country [268]
0
0
India
Query!
State/province [268]
0
0
Visakhapatnam
Query!
Country [269]
0
0
India
Query!
State/province [269]
0
0
West Bengal
Query!
Country [270]
0
0
Israel
Query!
State/province [270]
0
0
Afula
Query!
Country [271]
0
0
Israel
Query!
State/province [271]
0
0
Ashdod
Query!
Country [272]
0
0
Israel
Query!
State/province [272]
0
0
Haifa
Query!
Country [273]
0
0
Israel
Query!
State/province [273]
0
0
Jerusalem
Query!
Country [274]
0
0
Israel
Query!
State/province [274]
0
0
Kfar-Saba
Query!
Country [275]
0
0
Israel
Query!
State/province [275]
0
0
Nahariya
Query!
Country [276]
0
0
Israel
Query!
State/province [276]
0
0
Ramat Gan
Query!
Country [277]
0
0
Israel
Query!
State/province [277]
0
0
Rehovot
Query!
Country [278]
0
0
Israel
Query!
State/province [278]
0
0
Tel Aviv
Query!
Country [279]
0
0
Italy
Query!
State/province [279]
0
0
Bari
Query!
Country [280]
0
0
Italy
Query!
State/province [280]
0
0
Catania
Query!
Country [281]
0
0
Italy
Query!
State/province [281]
0
0
Catanzaro
Query!
Country [282]
0
0
Italy
Query!
State/province [282]
0
0
Firenze
Query!
Country [283]
0
0
Italy
Query!
State/province [283]
0
0
Genova
Query!
Country [284]
0
0
Italy
Query!
State/province [284]
0
0
Grosseto
Query!
Country [285]
0
0
Italy
Query!
State/province [285]
0
0
Milano
Query!
Country [286]
0
0
Italy
Query!
State/province [286]
0
0
Milan
Query!
Country [287]
0
0
Italy
Query!
State/province [287]
0
0
Modena
Query!
Country [288]
0
0
Italy
Query!
State/province [288]
0
0
Napoli
Query!
Country [289]
0
0
Italy
Query!
State/province [289]
0
0
Pisa
Query!
Country [290]
0
0
Italy
Query!
State/province [290]
0
0
Reggio Emilia
Query!
Country [291]
0
0
Italy
Query!
State/province [291]
0
0
Roma
Query!
Country [292]
0
0
Italy
Query!
State/province [292]
0
0
Rozzano
Query!
Country [293]
0
0
Italy
Query!
State/province [293]
0
0
Turin
Query!
Country [294]
0
0
Japan
Query!
State/province [294]
0
0
Chiba-shi
Query!
Country [295]
0
0
Japan
Query!
State/province [295]
0
0
Fukuoka-shi
Query!
Country [296]
0
0
Japan
Query!
State/province [296]
0
0
Fukushima-shi
Query!
Country [297]
0
0
Japan
Query!
State/province [297]
0
0
Hidaka-shi
Query!
Country [298]
0
0
Japan
Query!
State/province [298]
0
0
Hirakata-shi
Query!
Country [299]
0
0
Japan
Query!
State/province [299]
0
0
Hiroshima-shi
Query!
Country [300]
0
0
Japan
Query!
State/province [300]
0
0
Isehara-shi
Query!
Country [301]
0
0
Japan
Query!
State/province [301]
0
0
Kagoshima-shi
Query!
Country [302]
0
0
Japan
Query!
State/province [302]
0
0
Kashiwa
Query!
Country [303]
0
0
Japan
Query!
State/province [303]
0
0
Kitaadachi-gun
Query!
Country [304]
0
0
Japan
Query!
State/province [304]
0
0
Koto-ku
Query!
Country [305]
0
0
Japan
Query!
State/province [305]
0
0
Kumamoto-shi
Query!
Country [306]
0
0
Japan
Query!
State/province [306]
0
0
Kurume-shi
Query!
Country [307]
0
0
Japan
Query!
State/province [307]
0
0
Kyoto-shi
Query!
Country [308]
0
0
Japan
Query!
State/province [308]
0
0
Matsuyama-shi
Query!
Country [309]
0
0
Japan
Query!
State/province [309]
0
0
Nagoya-shi
Query!
Country [310]
0
0
Japan
Query!
State/province [310]
0
0
Niigata-shi
Query!
Country [311]
0
0
Japan
Query!
State/province [311]
0
0
Osaka-shi
Query!
Country [312]
0
0
Japan
Query!
State/province [312]
0
0
Ota-shi
Query!
Country [313]
0
0
Japan
Query!
State/province [313]
0
0
Sagamihara-shi
Query!
Country [314]
0
0
Japan
Query!
State/province [314]
0
0
Sapporo
Query!
Country [315]
0
0
Japan
Query!
State/province [315]
0
0
Sendai-shi
Query!
Country [316]
0
0
Japan
Query!
State/province [316]
0
0
Suita-shi
Query!
Country [317]
0
0
Japan
Query!
State/province [317]
0
0
Sunto-gun
Query!
Country [318]
0
0
Japan
Query!
State/province [318]
0
0
Takasaki-shi
Query!
Country [319]
0
0
Japan
Query!
State/province [319]
0
0
Tsu-shi
Query!
Country [320]
0
0
Japan
Query!
State/province [320]
0
0
Yokohama-shi
Query!
Country [321]
0
0
Korea, Republic of
Query!
State/province [321]
0
0
Busan
Query!
Country [322]
0
0
Korea, Republic of
Query!
State/province [322]
0
0
Daegu
Query!
Country [323]
0
0
Korea, Republic of
Query!
State/province [323]
0
0
Donggu
Query!
Country [324]
0
0
Korea, Republic of
Query!
State/province [324]
0
0
Goyang-si
Query!
Country [325]
0
0
Korea, Republic of
Query!
State/province [325]
0
0
Jeonnam
Query!
Country [326]
0
0
Korea, Republic of
Query!
State/province [326]
0
0
Seongbuk-Gu
Query!
Country [327]
0
0
Korea, Republic of
Query!
State/province [327]
0
0
Seoul
Query!
Country [328]
0
0
Malaysia
Query!
State/province [328]
0
0
George Town
Query!
Country [329]
0
0
Malaysia
Query!
State/province [329]
0
0
Georgetown
Query!
Country [330]
0
0
Malaysia
Query!
State/province [330]
0
0
Johor Bahru
Query!
Country [331]
0
0
Malaysia
Query!
State/province [331]
0
0
Kota Bharu
Query!
Country [332]
0
0
Malaysia
Query!
State/province [332]
0
0
Kuala Lumpur
Query!
Country [333]
0
0
Malaysia
Query!
State/province [333]
0
0
Kuching
Query!
Country [334]
0
0
Malaysia
Query!
State/province [334]
0
0
Melaka
Query!
Country [335]
0
0
Malaysia
Query!
State/province [335]
0
0
Sabah
Query!
Country [336]
0
0
Mexico
Query!
State/province [336]
0
0
Aguascalientes
Query!
Country [337]
0
0
Mexico
Query!
State/province [337]
0
0
Alc. Cuauhtémoc
Query!
Country [338]
0
0
Mexico
Query!
State/province [338]
0
0
Colonia Lindavista
Query!
Country [339]
0
0
Mexico
Query!
State/province [339]
0
0
Mexico City
Query!
Country [340]
0
0
Mexico
Query!
State/province [340]
0
0
Mexico
Query!
Country [341]
0
0
Mexico
Query!
State/province [341]
0
0
Monterrey
Query!
Country [342]
0
0
Mexico
Query!
State/province [342]
0
0
Mérida
Query!
Country [343]
0
0
Mexico
Query!
State/province [343]
0
0
San Luis Potosí
Query!
Country [344]
0
0
Mexico
Query!
State/province [344]
0
0
Toluca
Query!
Country [345]
0
0
Mexico
Query!
State/province [345]
0
0
Veracruz
Query!
Country [346]
0
0
Netherlands
Query!
State/province [346]
0
0
Dirksland
Query!
Country [347]
0
0
Netherlands
Query!
State/province [347]
0
0
Geleen
Query!
Country [348]
0
0
Netherlands
Query!
State/province [348]
0
0
Groningen
Query!
Country [349]
0
0
Netherlands
Query!
State/province [349]
0
0
Hoofddorp
Query!
Country [350]
0
0
Netherlands
Query!
State/province [350]
0
0
Rotterdam
Query!
Country [351]
0
0
Peru
Query!
State/province [351]
0
0
Arequipa
Query!
Country [352]
0
0
Peru
Query!
State/province [352]
0
0
Callao
Query!
Country [353]
0
0
Peru
Query!
State/province [353]
0
0
La Libertad
Query!
Country [354]
0
0
Peru
Query!
State/province [354]
0
0
Lima
Query!
Country [355]
0
0
Peru
Query!
State/province [355]
0
0
Trujillo
Query!
Country [356]
0
0
Philippines
Query!
State/province [356]
0
0
Bacolod
Query!
Country [357]
0
0
Philippines
Query!
State/province [357]
0
0
Cebu
Query!
Country [358]
0
0
Philippines
Query!
State/province [358]
0
0
Iloilo city
Query!
Country [359]
0
0
Philippines
Query!
State/province [359]
0
0
Manila
Query!
Country [360]
0
0
Philippines
Query!
State/province [360]
0
0
Quezon City
Query!
Country [361]
0
0
Poland
Query!
State/province [361]
0
0
Bialystok
Query!
Country [362]
0
0
Poland
Query!
State/province [362]
0
0
Grudziadz
Query!
Country [363]
0
0
Poland
Query!
State/province [363]
0
0
Koszalin
Query!
Country [364]
0
0
Poland
Query!
State/province [364]
0
0
Lublin
Query!
Country [365]
0
0
Poland
Query!
State/province [365]
0
0
Opole
Query!
Country [366]
0
0
Poland
Query!
State/province [366]
0
0
Poznan
Query!
Country [367]
0
0
Poland
Query!
State/province [367]
0
0
Racibórz
Query!
Country [368]
0
0
Poland
Query!
State/province [368]
0
0
Rzeszów
Query!
Country [369]
0
0
Poland
Query!
State/province [369]
0
0
Warszawa
Query!
Country [370]
0
0
Poland
Query!
State/province [370]
0
0
Wieliszew
Query!
Country [371]
0
0
Poland
Query!
State/province [371]
0
0
Lódz
Query!
Country [372]
0
0
Portugal
Query!
State/province [372]
0
0
Amadora
Query!
Country [373]
0
0
Portugal
Query!
State/province [373]
0
0
Braga
Query!
Country [374]
0
0
Portugal
Query!
State/province [374]
0
0
Guimarães
Query!
Country [375]
0
0
Portugal
Query!
State/province [375]
0
0
Lisboa
Query!
Country [376]
0
0
Portugal
Query!
State/province [376]
0
0
Matosinhos
Query!
Country [377]
0
0
Portugal
Query!
State/province [377]
0
0
Porto
Query!
Country [378]
0
0
Portugal
Query!
State/province [378]
0
0
Vila Nova de Gaia
Query!
Country [379]
0
0
Romania
Query!
State/province [379]
0
0
Baia Mare
Query!
Country [380]
0
0
Romania
Query!
State/province [380]
0
0
Brasov
Query!
Country [381]
0
0
Romania
Query!
State/province [381]
0
0
Cluj Napoca
Query!
Country [382]
0
0
Romania
Query!
State/province [382]
0
0
Cluj-Napoca
Query!
Country [383]
0
0
Romania
Query!
State/province [383]
0
0
Constanta
Query!
Country [384]
0
0
Romania
Query!
State/province [384]
0
0
Craiova
Query!
Country [385]
0
0
Romania
Query!
State/province [385]
0
0
Floresti
Query!
Country [386]
0
0
Romania
Query!
State/province [386]
0
0
Iasi
Query!
Country [387]
0
0
Romania
Query!
State/province [387]
0
0
Oradea
Query!
Country [388]
0
0
Romania
Query!
State/province [388]
0
0
Pitesti
Query!
Country [389]
0
0
Romania
Query!
State/province [389]
0
0
Sibiu
Query!
Country [390]
0
0
Romania
Query!
State/province [390]
0
0
Timisoara
Query!
Country [391]
0
0
Serbia
Query!
State/province [391]
0
0
Belgrade
Query!
Country [392]
0
0
Serbia
Query!
State/province [392]
0
0
Belgrad
Query!
Country [393]
0
0
Serbia
Query!
State/province [393]
0
0
Beograd
Query!
Country [394]
0
0
Serbia
Query!
State/province [394]
0
0
Kragujevac
Query!
Country [395]
0
0
Serbia
Query!
State/province [395]
0
0
Nis
Query!
Country [396]
0
0
Serbia
Query!
State/province [396]
0
0
Sremska Kamenica
Query!
Country [397]
0
0
Serbia
Query!
State/province [397]
0
0
Valjevo
Query!
Country [398]
0
0
Serbia
Query!
State/province [398]
0
0
Zrenjanin
Query!
Country [399]
0
0
Singapore
Query!
State/province [399]
0
0
Singapore
Query!
Country [400]
0
0
South Africa
Query!
State/province [400]
0
0
Amanzimtoti
Query!
Country [401]
0
0
South Africa
Query!
State/province [401]
0
0
Bloemfontein
Query!
Country [402]
0
0
South Africa
Query!
State/province [402]
0
0
George
Query!
Country [403]
0
0
South Africa
Query!
State/province [403]
0
0
Johannesburg
Query!
Country [404]
0
0
South Africa
Query!
State/province [404]
0
0
Pietermaritzburg
Query!
Country [405]
0
0
South Africa
Query!
State/province [405]
0
0
Pretoria
Query!
Country [406]
0
0
South Africa
Query!
State/province [406]
0
0
Soweto
Query!
Country [407]
0
0
Spain
Query!
State/province [407]
0
0
A Coruña
Query!
Country [408]
0
0
Spain
Query!
State/province [408]
0
0
Albacete
Query!
Country [409]
0
0
Spain
Query!
State/province [409]
0
0
Alcoy
Query!
Country [410]
0
0
Spain
Query!
State/province [410]
0
0
Alicant
Query!
Country [411]
0
0
Spain
Query!
State/province [411]
0
0
Alzira
Query!
Country [412]
0
0
Spain
Query!
State/province [412]
0
0
Badajoz
Query!
Country [413]
0
0
Spain
Query!
State/province [413]
0
0
Badalona
Query!
Country [414]
0
0
Spain
Query!
State/province [414]
0
0
Barakaldo
Query!
Country [415]
0
0
Spain
Query!
State/province [415]
0
0
Barcelona
Query!
Country [416]
0
0
Spain
Query!
State/province [416]
0
0
Cáceres
Query!
Country [417]
0
0
Spain
Query!
State/province [417]
0
0
Elche(Alicante)
Query!
Country [418]
0
0
Spain
Query!
State/province [418]
0
0
Galdakao
Query!
Country [419]
0
0
Spain
Query!
State/province [419]
0
0
Gerona
Query!
Country [420]
0
0
Spain
Query!
State/province [420]
0
0
Granada
Query!
Country [421]
0
0
Spain
Query!
State/province [421]
0
0
Jerez De La Frontera (Cádiz)
Query!
Country [422]
0
0
Spain
Query!
State/province [422]
0
0
L'Hospitalet de Llobregat
Query!
Country [423]
0
0
Spain
Query!
State/province [423]
0
0
Leganés
Query!
Country [424]
0
0
Spain
Query!
State/province [424]
0
0
Lérida
Query!
Country [425]
0
0
Spain
Query!
State/province [425]
0
0
Madrid
Query!
Country [426]
0
0
Spain
Query!
State/province [426]
0
0
Majadahonda
Query!
Country [427]
0
0
Spain
Query!
State/province [427]
0
0
Manresa
Query!
Country [428]
0
0
Spain
Query!
State/province [428]
0
0
Murcia
Query!
Country [429]
0
0
Spain
Query!
State/province [429]
0
0
Oviedo
Query!
Country [430]
0
0
Spain
Query!
State/province [430]
0
0
Parla
Query!
Country [431]
0
0
Spain
Query!
State/province [431]
0
0
Puerto De Sagunto
Query!
Country [432]
0
0
Spain
Query!
State/province [432]
0
0
Reus,Tarragona
Query!
Country [433]
0
0
Spain
Query!
State/province [433]
0
0
Salamanca
Query!
Country [434]
0
0
Spain
Query!
State/province [434]
0
0
San Juan de Alicante
Query!
Country [435]
0
0
Spain
Query!
State/province [435]
0
0
San Sebastián
Query!
Country [436]
0
0
Spain
Query!
State/province [436]
0
0
Santander
Query!
Country [437]
0
0
Spain
Query!
State/province [437]
0
0
Sevilla
Query!
Country [438]
0
0
Spain
Query!
State/province [438]
0
0
Teruel
Query!
Country [439]
0
0
Spain
Query!
State/province [439]
0
0
Toledo
Query!
Country [440]
0
0
Spain
Query!
State/province [440]
0
0
Valencia
Query!
Country [441]
0
0
Taiwan
Query!
State/province [441]
0
0
Hsinchu
Query!
Country [442]
0
0
Taiwan
Query!
State/province [442]
0
0
Kaohsiung
Query!
Country [443]
0
0
Taiwan
Query!
State/province [443]
0
0
Taichung
Query!
Country [444]
0
0
Taiwan
Query!
State/province [444]
0
0
Tainan City
Query!
Country [445]
0
0
Taiwan
Query!
State/province [445]
0
0
Tainan
Query!
Country [446]
0
0
Taiwan
Query!
State/province [446]
0
0
Taipei City
Query!
Country [447]
0
0
Taiwan
Query!
State/province [447]
0
0
Taipei
Query!
Country [448]
0
0
Thailand
Query!
State/province [448]
0
0
Bangkok
Query!
Country [449]
0
0
Thailand
Query!
State/province [449]
0
0
Khon Kaen
Query!
Country [450]
0
0
Thailand
Query!
State/province [450]
0
0
Phisanulok
Query!
Country [451]
0
0
Thailand
Query!
State/province [451]
0
0
Phitsanulok
Query!
Country [452]
0
0
Thailand
Query!
State/province [452]
0
0
Rachathewi
Query!
Country [453]
0
0
Thailand
Query!
State/province [453]
0
0
Songkla
Query!
Country [454]
0
0
Turkey
Query!
State/province [454]
0
0
Ankara
Query!
Country [455]
0
0
Turkey
Query!
State/province [455]
0
0
Aydin
Query!
Country [456]
0
0
Turkey
Query!
State/province [456]
0
0
Bursa
Query!
Country [457]
0
0
Turkey
Query!
State/province [457]
0
0
Dinar
Query!
Country [458]
0
0
Turkey
Query!
State/province [458]
0
0
Istambul
Query!
Country [459]
0
0
Turkey
Query!
State/province [459]
0
0
Istanbul
Query!
Country [460]
0
0
Turkey
Query!
State/province [460]
0
0
Izmir
Query!
Country [461]
0
0
Turkey
Query!
State/province [461]
0
0
Samsun
Query!
Country [462]
0
0
United Kingdom
Query!
State/province [462]
0
0
Brighton
Query!
Country [463]
0
0
United Kingdom
Query!
State/province [463]
0
0
Burton-on-Trent
Query!
Country [464]
0
0
United Kingdom
Query!
State/province [464]
0
0
Cambridge
Query!
Country [465]
0
0
United Kingdom
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State/province [465]
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0
Derby
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Country [466]
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0
United Kingdom
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State/province [466]
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0
Edinburgh
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Country [467]
0
0
United Kingdom
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State/province [467]
0
0
Guildford
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Country [468]
0
0
United Kingdom
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State/province [468]
0
0
Ipswich
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Country [469]
0
0
United Kingdom
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State/province [469]
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0
Keighley
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Country [470]
0
0
United Kingdom
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State/province [470]
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London
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Country [471]
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United Kingdom
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State/province [471]
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0
Manchester
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Country [472]
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0
United Kingdom
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State/province [472]
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Oxford
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Country [473]
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0
United Kingdom
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State/province [473]
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Peterborough
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Country [474]
0
0
United Kingdom
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State/province [474]
0
0
Stoke on Trent
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Country [475]
0
0
United Kingdom
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State/province [475]
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0
Sutton
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Country [476]
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0
Vietnam
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State/province [476]
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0
Hanoi
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Country [477]
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0
Vietnam
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State/province [477]
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0
Ho Chi Minh city
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Country [478]
0
0
Vietnam
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State/province [478]
0
0
Ho Chi Minh
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Country [479]
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0
Vietnam
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State/province [479]
0
0
Hue
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to
standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate
or high risk for disease recurrence who completed definitive locoregional therapy (with or
without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and
up to 5 years. The planned duration of treatment in either arm of the study is 60 months.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05774951
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
0
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Fax
0
0
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Email
0
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Contact person for public queries
Name
0
0
AstraZeneca Clinical Study Information Center
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Address
0
0
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Country
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0
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Phone
0
0
1-877-240-9479
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05774951
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