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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04961996




Registration number
NCT04961996
Ethics application status
Date submitted
5/07/2021
Date registered
14/07/2021

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)
Scientific title
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer
Secondary ID [1] 0 0
2021-000129-28
Secondary ID [2] 0 0
GO42784
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Giredestrant
Treatment: Drugs - Endocrine Therapy of Physician's Choice
Treatment: Drugs - LHRH Agonist
Treatment: Drugs - Abemaciclib

Experimental: Arm A: Giredestrant -

Active comparator: Arm B: Endocrine Therapy of Physician's Choice -

Experimental: Substudy: Giredestrant + Abemaciclib, Then Giredestrant - In this substudy, participants will receive giredestrant in combination with abemaciclib for up to 2 years. Participants will continue with giredestrant monotherapy for an additional 3 years in order to complete a total of 5 years on study treatment.


Treatment: Drugs: Giredestrant
Giredestrant 30 milligrams (mg) will be administered orally once a day (QD) on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).

Treatment: Drugs: Endocrine Therapy of Physician's Choice
The endocrine therapy of physician's choice (TPC) is limited to tamoxifen or one of the specified third generation aromatase inhibitors: letrozole, anastrozole, or exemestane. Participants will receive TPC daily on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first). Continuing TPC after 5 years is at the discretion of the investigator and per local standard of care. Dose administration of TPC should be performed in accordance with the local prescribing information for the respective product.

Treatment: Drugs: LHRH Agonist
A luteinizing hormone-releasing hormone (LHRH) agonist will be administered to male participants and premenopausal/perimenopausal participants according to local prescribing information. The investigator may determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Treatment: Drugs: Abemaciclib
Abemaciclib 150 mg will be administered orally (PO) twice a day (BID) on Days 1-28 during each 28-day cycle for 2 years or until disease recurrence or unacceptable toxicity (whichever occurs first).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Disease-Free Survival (IDFS), Excluding Second Primary Non-Breast Cancers
Timepoint [1] 0 0
From randomization to first occurrence of an IDFS event (up to 10 years)
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From randomization to death from any cause (up to 10 years)
Secondary outcome [2] 0 0
Invasive Disease-Free Survival (IDFS), Including Second Primary Non-Breast Cancers
Timepoint [2] 0 0
From randomization to first occurrence of an IDFS event (up to 10 years)
Secondary outcome [3] 0 0
Disease-Free Survival (DFS)
Timepoint [3] 0 0
From randomization to first occurrence of a DFS event (up to 10 years)
Secondary outcome [4] 0 0
Distant Recurrence-Free Interval (DRFI)
Timepoint [4] 0 0
From randomization to first occurrence of a DFRI event (up to 10 years)
Secondary outcome [5] 0 0
Locoregional Recurrence-Free Interval (LRRFI)
Timepoint [5] 0 0
From randomization to first occurrence of a LRRFI event (up to 10 years)
Secondary outcome [6] 0 0
Mean Physical Functioning Scale Score at Specified Timepoints, Assessed Using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Timepoint [6] 0 0
Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary outcome [7] 0 0
Change from Baseline in the Mean Physical Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
Timepoint [7] 0 0
Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary outcome [8] 0 0
Mean Role Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
Timepoint [8] 0 0
Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary outcome [9] 0 0
Change from Baseline in the Mean Role Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
Timepoint [9] 0 0
Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary outcome [10] 0 0
Mean Global Health Status/Quality of Life (QoL) Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
Timepoint [10] 0 0
Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary outcome [11] 0 0
Change from Baseline in the Mean Global Health Status/Quality of Life (QoL) Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30
Timepoint [11] 0 0
Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary outcome [12] 0 0
Change from Baseline in the EQ 5D-5L Index-Based Score at Specified Timepoints
Timepoint [12] 0 0
Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary outcome [13] 0 0
Change from Baseline in the EQ 5D-5L Visual Analogue Scale (VAS) Score at Specified Timepoints
Timepoint [13] 0 0
Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)
Secondary outcome [14] 0 0
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)
Timepoint [14] 0 0
From start of treatment until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [15] 0 0
Plasma Concentrations of Giredestrant at Specified Timepoints
Timepoint [15] 0 0
Predose and 3-4 hours postdose on Day 1 of Cycles 1 and 2, and predose on Day 1 of Cycles 3 and 6 (1 cycle is 28 days)
Secondary outcome [16] 0 0
Substudy: Incidence of Grade =3 Adverse Events with Giredestrant in Combination with Abemaciclib
Timepoint [16] 0 0
From first dose of study treatment until 28 days after the last dose of treatment with the combination of giredestrant and abemaciclib or until the end of Year 2, whichever occurs first (up to 2 years)
Secondary outcome [17] 0 0
Substudy: Incidence and Severity of Adverse Events with Giredestrant in Combination with Abemaciclib, with Severity Determined According to NCI-CTCAE v5.0
Timepoint [17] 0 0
From first dose of study treatment until 28 days after the last dose of treatment with the combination of giredestrant and abemaciclib or until the end of Year 2, whichever occurs first (up to 2 years)

Eligibility
Key inclusion criteria
Primary Study

* Documented estrogen receptor (ER)-positive and HER2-negative breast tumor, as assessed locally on a primary disease specimen
* Participants who have multicentric (the presence of two of more tumor foci within different quadrants of the same breast) and/or multifocal (the presence of two or more tumor foci within a single quadrant of the breast) breast cancer are also eligible if all examined tumors meet pathologic criteria for ER positivity and HER2 negativity
* Participants must have undergone definitive surgery of their primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection [ALND] and/or sentinel lymph node biopsy [SLNB])
* Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization. Participants may also have received neoadjuvant chemotherapy. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and randomization.
* Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade 1 or better (except alopecia, Grade =2 peripheral neuropathy, arthralgia or other toxicities not considered a safety risk for the participant per the investigator's judgment)
* Participants have received (neo)adjuvant chemotherapy and/or had surgery and had no prior endocrine therapy are eligible, provided that they are enrolled within 12 months following definitive breast cancer surgery
* Participants who have confirmed availability of an untreated primary breast tumor tissue specimen suitable for biomarker testing (i.e., representative archived formalin-fixed, paraffin-embedded [FFPE] tissue block [preferred] or 15-20 slides containing unstained, freshly cut, serial sections), with associated de-identified pathology report is required. Although 15-20 slides are preferred, if only 10-14 slides are available, the individual may still be eligible for the study.
* Participants with node-positive and node-negative disease are eligible provided they meet additional risk criteria as defined in the protocol
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
* Able and willing to swallow, retain, and absorb oral medication
* Adequate organ function

Substudy

To be eligible for substudy participation, in addition to meeting the inclusion criteria in the primary protocol, participants must also meet the following modified criteria:

- Patients who received adjuvant radiotherapy must have completed radiotherapy prior to enrollment, and patients must have recovered (to Grade =1) from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment.

Primary Study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 10 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of the endocrine therapy of physician's choice
* Received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research judged by the sponsor not to be scientifically or medically compatible with this study
* Receiving or planning to receive a CDK4/6 inhibitor as (neo)adjuvant therapy. A short course of up to 12 weeks of neoadjuvant or adjuvant treatment with CDK4/6 inhibitor therapy prior to randomization is allowed.
* Active cardiac disease or history of cardiac dysfunction
* Diagnosed with Stage IV breast cancer
* A history of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS). Participants with a history of contralateral DCIS treated by only local regional therapy at any time may be eligible.
* A history of any other malignancy within 3 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, or Stage I uterine cancer
* Any prior endocrine treatment with selective ER modulators (e.g., tamoxifen), degraders, or aromatase inhibitors. A short course of neoadjuvant or adjuvant endocrine therapy (up to 12 weeks) is allowed.
* Clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis
* Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
* Known allergy or hypersensitivity to any of the study drugs or any of their excipients
* Pre- and perimenopausal participants or male participants who have a known hypersensitivity to LHRH agonists
* A documented history of hemorrhagic diathesis, coagulopathy, or thromboembolism
* Renal dysfunction that requires dialysis
* A major surgical procedure unrelated to breast cancer within 28 days prior to randomization
* A serious infection requiring oral or IV antibiotics within 14 days prior to screening or other clinically significant infection (e.g., COVID-19) within 14 days prior to screening
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
* Unable or unwilling to comply with the requirements of the protocol in the opinion of the investigator

Substudy

Potential participants are excluded from the substudy if any criteria from the primary study or the following criteria apply:

* Prior participation in the GO42784 primary study
* Received a CDK4/6i as (neo)adjuvant therapy prior to enrollment
* Treatment with moderate CYP3A inducers, strong CYP3A inducers or strong CYP3A inhibitors within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/11/2033
Actual
Sample size
Target
4200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [2] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [4] 0 0
Liverpool Hospital; Cancer Therapy Centre - Liverpool
Recruitment hospital [5] 0 0
Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research - North Sydney
Recruitment hospital [6] 0 0
Westmead Hospital; Pharmacy Distribution Centre - Northmead
Recruitment hospital [7] 0 0
North Coast Cancer Institute - Port Macquarie - Port Macquarie
Recruitment hospital [8] 0 0
Wesley Medical Centre; Clinic For Haematology and Oncology - Auchenflower
Recruitment hospital [9] 0 0
Mater Cancer Care Centre - Brisbane
Recruitment hospital [10] 0 0
Cairns Hospital; Renal Services - Cairns
Recruitment hospital [11] 0 0
Townsville Hospital - Townsville
Recruitment hospital [12] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [13] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [14] 0 0
St Andrews Medical Centre - Adelaide
Recruitment hospital [15] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [16] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [17] 0 0
ICON Cancer Care Hobart - Hobart
Recruitment hospital [18] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [19] 0 0
Northern Hospital - Epping
Recruitment hospital [20] 0 0
Frankston Hospital; Oncology/Haematology - Frankston
Recruitment hospital [21] 0 0
Maroondah Hospital; Breast Clinic - Ringwood East
Recruitment hospital [22] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [23] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [24] 0 0
South West Healthcare - Warrnambool
Recruitment hospital [25] 0 0
Ballarat Oncology & Haematology - Wendouree
Recruitment hospital [26] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2200 - Bankstown
Recruitment postcode(s) [3] 0 0
2560 - Campbelltown
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2060 - North Sydney
Recruitment postcode(s) [6] 0 0
2152 - Northmead
Recruitment postcode(s) [7] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [8] 0 0
4066 - Auchenflower
Recruitment postcode(s) [9] 0 0
4101 - Brisbane
Recruitment postcode(s) [10] 0 0
4870 - Cairns
Recruitment postcode(s) [11] 0 0
4810 - Townsville
Recruitment postcode(s) [12] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [13] 0 0
5000 - Adelaide
Recruitment postcode(s) [14] 0 0
5042 - Bedford Park
Recruitment postcode(s) [15] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [16] 0 0
7000 - Hobart
Recruitment postcode(s) [17] 0 0
3550 - Bendigo
Recruitment postcode(s) [18] 0 0
3076 - Epping
Recruitment postcode(s) [19] 0 0
3199 - Frankston
Recruitment postcode(s) [20] 0 0
3135 - Ringwood East
Recruitment postcode(s) [21] 0 0
3630 - Shepparton
Recruitment postcode(s) [22] 0 0
3021 - St Albans
Recruitment postcode(s) [23] 0 0
3280 - Warrnambool
Recruitment postcode(s) [24] 0 0
3355 - Wendouree
Recruitment postcode(s) [25] 0 0
6009 - Nedlands
Recruitment outside Australia
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Alabama
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Colorado
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Connecticut
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Louisiana
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Massachusetts
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Minnesota
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Missouri
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Nebraska
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Nevada
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New York
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Texas
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Argentina
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Buenos Aires
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Caba
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Argentina
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Cipoletti
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Cordoba
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Argentina
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Córdoba
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Argentina
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Jujuy
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La Rioja
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Argentina
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Mar Del Plata
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Argentina
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Pergamino
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Argentina
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Recoleta
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Argentina
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Rosario
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Argentina
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San Juan
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Argentina
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San Miguel de Tucuman
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Argentina
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San Nicolás
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Argentina
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Viedma
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Rankweil
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Austria
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Salzburg
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Austria
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St. Pölten
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Austria
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St. Veit
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Austria
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Steyr
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Austria
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Wels
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Austria
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Wien
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Belgium
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Belgium
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Belgium
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Charleroi
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Belgium
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Leuven
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Belgium
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Libramont-Chevigny
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Belgium
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Liege
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Belgium
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Liège
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Belgium
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Namur
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Belgium
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Wilrijk
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Bosnia and Herzegovina
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Banja Luka
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Bosnia and Herzegovina
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Mostar
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Bosnia and Herzegovina
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Sarajevo
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Bosnia and Herzegovina
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Tuzla
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Brazil
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BA
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Brazil
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ES
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Brazil
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GO
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Brazil
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MG
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Brazil
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PA
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Brazil
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PE
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Brazil
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RJ
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Brazil
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RS
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Brazil
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SC
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Brazil
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SP
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Bulgaria
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Burgas
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Bulgaria
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Panagyurishte
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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Chile
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La Serena
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Chile
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Peñalolen
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Chile
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Providencia
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Chile
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Puerto Montt
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Chile
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Rancagua
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Chile
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Santiago
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Chile
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Talca
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Chile
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Temuco
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Chile
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Vina Del Mar
Country [101] 0 0
Chile
State/province [101] 0 0
Viña del Mar
Country [102] 0 0
China
State/province [102] 0 0
Beijing
Country [103] 0 0
China
State/province [103] 0 0
Changchun City
Country [104] 0 0
China
State/province [104] 0 0
Changchun
Country [105] 0 0
China
State/province [105] 0 0
Changsha CITY
Country [106] 0 0
China
State/province [106] 0 0
Chengdu
Country [107] 0 0
China
State/province [107] 0 0
Dalian
Country [108] 0 0
China
State/province [108] 0 0
Fuzhou City
Country [109] 0 0
China
State/province [109] 0 0
Guangzhou
Country [110] 0 0
China
State/province [110] 0 0
Hangzhou City
Country [111] 0 0
China
State/province [111] 0 0
Hangzhou
Country [112] 0 0
China
State/province [112] 0 0
Harbin
Country [113] 0 0
China
State/province [113] 0 0
Hefei City
Country [114] 0 0
China
State/province [114] 0 0
Jinan City
Country [115] 0 0
China
State/province [115] 0 0
Kunming
Country [116] 0 0
China
State/province [116] 0 0
Linyi City
Country [117] 0 0
China
State/province [117] 0 0
Nanchang City
Country [118] 0 0
China
State/province [118] 0 0
Nanning City
Country [119] 0 0
China
State/province [119] 0 0
Neijiang
Country [120] 0 0
China
State/province [120] 0 0
Shanghai City
Country [121] 0 0
China
State/province [121] 0 0
ShenYang
Country [122] 0 0
China
State/province [122] 0 0
Shijiazhuang
Country [123] 0 0
China
State/province [123] 0 0
Tianjin
Country [124] 0 0
China
State/province [124] 0 0
Wenzhou City
Country [125] 0 0
China
State/province [125] 0 0
Wuhan City
Country [126] 0 0
China
State/province [126] 0 0
Wuhan
Country [127] 0 0
China
State/province [127] 0 0
Xi'an City
Country [128] 0 0
China
State/province [128] 0 0
Xi'an
Country [129] 0 0
China
State/province [129] 0 0
Xiamen
Country [130] 0 0
China
State/province [130] 0 0
Xuzhou
Country [131] 0 0
China
State/province [131] 0 0
Zhejiang
Country [132] 0 0
China
State/province [132] 0 0
Zhengzhou
Country [133] 0 0
Colombia
State/province [133] 0 0
Cali
Country [134] 0 0
Colombia
State/province [134] 0 0
Floridablanca
Country [135] 0 0
Colombia
State/province [135] 0 0
Monteria
Country [136] 0 0
Colombia
State/province [136] 0 0
Pereira
Country [137] 0 0
Colombia
State/province [137] 0 0
Valledupar
Country [138] 0 0
Costa Rica
State/province [138] 0 0
Moravia
Country [139] 0 0
Costa Rica
State/province [139] 0 0
San Jose
Country [140] 0 0
Costa Rica
State/province [140] 0 0
San José
Country [141] 0 0
Croatia
State/province [141] 0 0
Osijek
Country [142] 0 0
Croatia
State/province [142] 0 0
Pula
Country [143] 0 0
Croatia
State/province [143] 0 0
Split
Country [144] 0 0
Croatia
State/province [144] 0 0
Varazdin
Country [145] 0 0
Croatia
State/province [145] 0 0
Zagreb
Country [146] 0 0
Czechia
State/province [146] 0 0
Olomouc
Country [147] 0 0
Czechia
State/province [147] 0 0
Praha 2
Country [148] 0 0
Czechia
State/province [148] 0 0
Praha 5
Country [149] 0 0
Czechia
State/province [149] 0 0
Praha
Country [150] 0 0
Egypt
State/province [150] 0 0
Alexandria
Country [151] 0 0
Egypt
State/province [151] 0 0
Cairo
Country [152] 0 0
Egypt
State/province [152] 0 0
Dakahlia
Country [153] 0 0
Egypt
State/province [153] 0 0
Old Cairo
Country [154] 0 0
Finland
State/province [154] 0 0
Helsinki
Country [155] 0 0
Finland
State/province [155] 0 0
Tampere
Country [156] 0 0
Finland
State/province [156] 0 0
Turku
Country [157] 0 0
France
State/province [157] 0 0
Amiens
Country [158] 0 0
France
State/province [158] 0 0
Argenteuil
Country [159] 0 0
France
State/province [159] 0 0
Brest
Country [160] 0 0
France
State/province [160] 0 0
Caen
Country [161] 0 0
France
State/province [161] 0 0
Grenoble
Country [162] 0 0
France
State/province [162] 0 0
La Roche Sur Yon
Country [163] 0 0
France
State/province [163] 0 0
Le Mans
Country [164] 0 0
France
State/province [164] 0 0
Lille
Country [165] 0 0
France
State/province [165] 0 0
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Country [166] 0 0
France
State/province [166] 0 0
Marseille
Country [167] 0 0
France
State/province [167] 0 0
Montpellier
Country [168] 0 0
France
State/province [168] 0 0
Nantes
Country [169] 0 0
France
State/province [169] 0 0
Paris
Country [170] 0 0
France
State/province [170] 0 0
Plérin
Country [171] 0 0
France
State/province [171] 0 0
Rennes Cedex
Country [172] 0 0
France
State/province [172] 0 0
Rouen
Country [173] 0 0
France
State/province [173] 0 0
St Cloud
Country [174] 0 0
France
State/province [174] 0 0
Strasbourg
Country [175] 0 0
France
State/province [175] 0 0
Villejuif
Country [176] 0 0
Georgia
State/province [176] 0 0
Batumi
Country [177] 0 0
Georgia
State/province [177] 0 0
Tbilisi
Country [178] 0 0
Germany
State/province [178] 0 0
Augsburg
Country [179] 0 0
Germany
State/province [179] 0 0
Berlin
Country [180] 0 0
Germany
State/province [180] 0 0
Bonn
Country [181] 0 0
Germany
State/province [181] 0 0
Bottrop
Country [182] 0 0
Germany
State/province [182] 0 0
Chemnitz
Country [183] 0 0
Germany
State/province [183] 0 0
Erlangen
Country [184] 0 0
Germany
State/province [184] 0 0
Essen
Country [185] 0 0
Germany
State/province [185] 0 0
Georgsmarienhutte
Country [186] 0 0
Germany
State/province [186] 0 0
Gera
Country [187] 0 0
Germany
State/province [187] 0 0
Hamburg
Country [188] 0 0
Germany
State/province [188] 0 0
Hannover
Country [189] 0 0
Germany
State/province [189] 0 0
Karlsruhe
Country [190] 0 0
Germany
State/province [190] 0 0
Lübeck
Country [191] 0 0
Germany
State/province [191] 0 0
Mainz
Country [192] 0 0
Germany
State/province [192] 0 0
Mannheim
Country [193] 0 0
Germany
State/province [193] 0 0
Mönchengladbach
Country [194] 0 0
Germany
State/province [194] 0 0
Ravensburg
Country [195] 0 0
Germany
State/province [195] 0 0
Schweinfurt
Country [196] 0 0
Germany
State/province [196] 0 0
Velbert
Country [197] 0 0
Greece
State/province [197] 0 0
Athens
Country [198] 0 0
Greece
State/province [198] 0 0
Athina
Country [199] 0 0
Greece
State/province [199] 0 0
Chaidari
Country [200] 0 0
Greece
State/province [200] 0 0
Cholargos
Country [201] 0 0
Greece
State/province [201] 0 0
Faliro
Country [202] 0 0
Greece
State/province [202] 0 0
Heraklio
Country [203] 0 0
Greece
State/province [203] 0 0
Ioannina
Country [204] 0 0
Greece
State/province [204] 0 0
Larissa
Country [205] 0 0
Greece
State/province [205] 0 0
Marousi
Country [206] 0 0
Greece
State/province [206] 0 0
Panorama
Country [207] 0 0
Greece
State/province [207] 0 0
Patras
Country [208] 0 0
Greece
State/province [208] 0 0
Thessaloniki
Country [209] 0 0
Guatemala
State/province [209] 0 0
Ciudad de Guatemala
Country [210] 0 0
Guatemala
State/province [210] 0 0
Guatemala
Country [211] 0 0
Guatemala
State/province [211] 0 0
Quetzaltenango
Country [212] 0 0
Hong Kong
State/province [212] 0 0
Chai Wan
Country [213] 0 0
Hong Kong
State/province [213] 0 0
Hong Kong
Country [214] 0 0
Hungary
State/province [214] 0 0
Budapest
Country [215] 0 0
Hungary
State/province [215] 0 0
Debrecen
Country [216] 0 0
Hungary
State/province [216] 0 0
Miskolc
Country [217] 0 0
Hungary
State/province [217] 0 0
Tatabánya
Country [218] 0 0
Hungary
State/province [218] 0 0
Zalaegerszeg
Country [219] 0 0
India
State/province [219] 0 0
Andhra Pradesh
Country [220] 0 0
India
State/province [220] 0 0
Bihar
Country [221] 0 0
India
State/province [221] 0 0
Gujarat
Country [222] 0 0
India
State/province [222] 0 0
Karnataka
Country [223] 0 0
India
State/province [223] 0 0
Maharashtra
Country [224] 0 0
India
State/province [224] 0 0
Odisha
Country [225] 0 0
India
State/province [225] 0 0
Tamil NADU
Country [226] 0 0
India
State/province [226] 0 0
Uttar Pradesh
Country [227] 0 0
India
State/province [227] 0 0
WEST Bengal
Country [228] 0 0
Ireland
State/province [228] 0 0
Cork
Country [229] 0 0
Ireland
State/province [229] 0 0
Dublin
Country [230] 0 0
Ireland
State/province [230] 0 0
Galway
Country [231] 0 0
Ireland
State/province [231] 0 0
Limerick
Country [232] 0 0
Ireland
State/province [232] 0 0
Waterford
Country [233] 0 0
Israel
State/province [233] 0 0
Be'er Ya'akov
Country [234] 0 0
Israel
State/province [234] 0 0
Beer Sheva
Country [235] 0 0
Israel
State/province [235] 0 0
Ramat Gan
Country [236] 0 0
Israel
State/province [236] 0 0
Tel Aviv
Country [237] 0 0
Italy
State/province [237] 0 0
Abruzzo
Country [238] 0 0
Italy
State/province [238] 0 0
Campania
Country [239] 0 0
Italy
State/province [239] 0 0
Emilia-Romagna
Country [240] 0 0
Italy
State/province [240] 0 0
Lazio
Country [241] 0 0
Italy
State/province [241] 0 0
Lombardia
Country [242] 0 0
Italy
State/province [242] 0 0
Toscana
Country [243] 0 0
Italy
State/province [243] 0 0
Veneto
Country [244] 0 0
Japan
State/province [244] 0 0
Chuo
Country [245] 0 0
Japan
State/province [245] 0 0
Hiroshima
Country [246] 0 0
Japan
State/province [246] 0 0
Hokkaido
Country [247] 0 0
Japan
State/province [247] 0 0
Kagoshima
Country [248] 0 0
Japan
State/province [248] 0 0
Kanagawa
Country [249] 0 0
Japan
State/province [249] 0 0
Kumamoto
Country [250] 0 0
Japan
State/province [250] 0 0
Miyagi
Country [251] 0 0
Japan
State/province [251] 0 0
Naha-shi
Country [252] 0 0
Japan
State/province [252] 0 0
Osaka
Country [253] 0 0
Japan
State/province [253] 0 0
Saitama
Country [254] 0 0
Japan
State/province [254] 0 0
Tokyo
Country [255] 0 0
Kenya
State/province [255] 0 0
Eldoret
Country [256] 0 0
Kenya
State/province [256] 0 0
Nairobi
Country [257] 0 0
Korea, Republic of
State/province [257] 0 0
Cheongju si
Country [258] 0 0
Korea, Republic of
State/province [258] 0 0
Dongnam-gu, Cheonan-si
Country [259] 0 0
Korea, Republic of
State/province [259] 0 0
Gangwon-do
Country [260] 0 0
Korea, Republic of
State/province [260] 0 0
Gyeonggi-do
Country [261] 0 0
Korea, Republic of
State/province [261] 0 0
Incheon
Country [262] 0 0
Korea, Republic of
State/province [262] 0 0
Seongnam-si
Country [263] 0 0
Korea, Republic of
State/province [263] 0 0
Seoul
Country [264] 0 0
Korea, Republic of
State/province [264] 0 0
Suwon City
Country [265] 0 0
Korea, Republic of
State/province [265] 0 0
Ulsan
Country [266] 0 0
Latvia
State/province [266] 0 0
R?ga
Country [267] 0 0
Malaysia
State/province [267] 0 0
FED. Territory OF Kuala Lumpur
Country [268] 0 0
Malaysia
State/province [268] 0 0
Federal Territory OF Putrajaya
Country [269] 0 0
Malaysia
State/province [269] 0 0
Kedah
Country [270] 0 0
Malaysia
State/province [270] 0 0
Sarawak
Country [271] 0 0
Malaysia
State/province [271] 0 0
Selangor
Country [272] 0 0
Malaysia
State/province [272] 0 0
Penang
Country [273] 0 0
Mexico
State/province [273] 0 0
BAJA California
Country [274] 0 0
Mexico
State/province [274] 0 0
Durango
Country [275] 0 0
Mexico
State/province [275] 0 0
Guanajuato
Country [276] 0 0
Mexico
State/province [276] 0 0
Jalisco
Country [277] 0 0
Mexico
State/province [277] 0 0
Mexico CITY (federal District)
Country [278] 0 0
Mexico
State/province [278] 0 0
Nuevo LEON
Country [279] 0 0
Mexico
State/province [279] 0 0
Oaxaca
Country [280] 0 0
Mexico
State/province [280] 0 0
Puebla
Country [281] 0 0
Mexico
State/province [281] 0 0
Queretaro
Country [282] 0 0
Mexico
State/province [282] 0 0
Sinaloa
Country [283] 0 0
Mexico
State/province [283] 0 0
Yucatan
Country [284] 0 0
Mexico
State/province [284] 0 0
Aguascalientes
Country [285] 0 0
Mexico
State/province [285] 0 0
Mexico
Country [286] 0 0
Mexico
State/province [286] 0 0
San Luis Potosí
Country [287] 0 0
Netherlands
State/province [287] 0 0
'S-Gravenhage
Country [288] 0 0
Netherlands
State/province [288] 0 0
Eindhoven
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Netherlands
State/province [289] 0 0
Venlo
Country [290] 0 0
North Macedonia
State/province [290] 0 0
Bitola
Country [291] 0 0
North Macedonia
State/province [291] 0 0
Skopje
Country [292] 0 0
Peru
State/province [292] 0 0
Bellavista
Country [293] 0 0
Peru
State/province [293] 0 0
Jesus Maria
Country [294] 0 0
Peru
State/province [294] 0 0
Lima
Country [295] 0 0
Peru
State/province [295] 0 0
Trujillo
Country [296] 0 0
Philippines
State/province [296] 0 0
Bacolod City
Country [297] 0 0
Philippines
State/province [297] 0 0
Baguio City
Country [298] 0 0
Philippines
State/province [298] 0 0
Davao City
Country [299] 0 0
Philippines
State/province [299] 0 0
Iloilo City
Country [300] 0 0
Philippines
State/province [300] 0 0
Manila
Country [301] 0 0
Philippines
State/province [301] 0 0
Pasig City
Country [302] 0 0
Philippines
State/province [302] 0 0
Quezon City
Country [303] 0 0
Poland
State/province [303] 0 0
Bydgoszcz
Country [304] 0 0
Poland
State/province [304] 0 0
Gdynia
Country [305] 0 0
Poland
State/province [305] 0 0
Gliwice
Country [306] 0 0
Poland
State/province [306] 0 0
Grudziadz
Country [307] 0 0
Poland
State/province [307] 0 0
Lodz
Country [308] 0 0
Poland
State/province [308] 0 0
Lublin
Country [309] 0 0
Poland
State/province [309] 0 0
Skórzewo
Country [310] 0 0
Poland
State/province [310] 0 0
Warszawa
Country [311] 0 0
Portugal
State/province [311] 0 0
Guimarães
Country [312] 0 0
Portugal
State/province [312] 0 0
Lisboa
Country [313] 0 0
Portugal
State/province [313] 0 0
Lisbon
Country [314] 0 0
Portugal
State/province [314] 0 0
Loures
Country [315] 0 0
Portugal
State/province [315] 0 0
Porto
Country [316] 0 0
Portugal
State/province [316] 0 0
Vila Nova de Gaia
Country [317] 0 0
Portugal
State/province [317] 0 0
Vila Real
Country [318] 0 0
Romania
State/province [318] 0 0
Bucure?ti
Country [319] 0 0
Romania
State/province [319] 0 0
Cluj-napoca
Country [320] 0 0
Romania
State/province [320] 0 0
Cluj-Napoca
Country [321] 0 0
Romania
State/province [321] 0 0
Craiova
Country [322] 0 0
Romania
State/province [322] 0 0
Iasi
Country [323] 0 0
Romania
State/province [323] 0 0
Timi?oara
Country [324] 0 0
Serbia
State/province [324] 0 0
Belgrade
Country [325] 0 0
Serbia
State/province [325] 0 0
Kladovo
Country [326] 0 0
Serbia
State/province [326] 0 0
Sremska Kamenica
Country [327] 0 0
Serbia
State/province [327] 0 0
Zrenjanin
Country [328] 0 0
Slovakia
State/province [328] 0 0
Bratislava
Country [329] 0 0
Slovakia
State/province [329] 0 0
Kosice
Country [330] 0 0
Slovenia
State/province [330] 0 0
Ljubljana
Country [331] 0 0
South Africa
State/province [331] 0 0
Cape Town
Country [332] 0 0
South Africa
State/province [332] 0 0
City Of Johannesburg
Country [333] 0 0
South Africa
State/province [333] 0 0
George
Country [334] 0 0
South Africa
State/province [334] 0 0
Johannesburg
Country [335] 0 0
South Africa
State/province [335] 0 0
Port Elizabeth
Country [336] 0 0
South Africa
State/province [336] 0 0
Pretoria
Country [337] 0 0
South Africa
State/province [337] 0 0
Randfontein
Country [338] 0 0
Spain
State/province [338] 0 0
Alicante
Country [339] 0 0
Spain
State/province [339] 0 0
Barcelona
Country [340] 0 0
Spain
State/province [340] 0 0
Burgos
Country [341] 0 0
Spain
State/province [341] 0 0
Cadiz
Country [342] 0 0
Spain
State/province [342] 0 0
Castellon
Country [343] 0 0
Spain
State/province [343] 0 0
Cordoba
Country [344] 0 0
Spain
State/province [344] 0 0
Guipuzcoa
Country [345] 0 0
Spain
State/province [345] 0 0
Islas Baleares
Country [346] 0 0
Spain
State/province [346] 0 0
LA Coruña
Country [347] 0 0
Spain
State/province [347] 0 0
LAS Palmas
Country [348] 0 0
Spain
State/province [348] 0 0
Lerida
Country [349] 0 0
Spain
State/province [349] 0 0
Madrid
Country [350] 0 0
Spain
State/province [350] 0 0
Navarra
Country [351] 0 0
Spain
State/province [351] 0 0
Pontevedra
Country [352] 0 0
Spain
State/province [352] 0 0
Sevilla
Country [353] 0 0
Spain
State/province [353] 0 0
Tarragona
Country [354] 0 0
Spain
State/province [354] 0 0
Tenerife
Country [355] 0 0
Spain
State/province [355] 0 0
Vizcaya
Country [356] 0 0
Spain
State/province [356] 0 0
Albacete
Country [357] 0 0
Spain
State/province [357] 0 0
Avila
Country [358] 0 0
Spain
State/province [358] 0 0
Caceres
Country [359] 0 0
Spain
State/province [359] 0 0
Girona
Country [360] 0 0
Spain
State/province [360] 0 0
Granada
Country [361] 0 0
Spain
State/province [361] 0 0
Huelva
Country [362] 0 0
Spain
State/province [362] 0 0
Jaen
Country [363] 0 0
Spain
State/province [363] 0 0
Malaga
Country [364] 0 0
Spain
State/province [364] 0 0
Murcia
Country [365] 0 0
Spain
State/province [365] 0 0
Valencia
Country [366] 0 0
Spain
State/province [366] 0 0
Valladolid
Country [367] 0 0
Spain
State/province [367] 0 0
Zaragoza
Country [368] 0 0
Sweden
State/province [368] 0 0
Jönköping
Country [369] 0 0
Sweden
State/province [369] 0 0
Stockholm
Country [370] 0 0
Sweden
State/province [370] 0 0
Sundsvall
Country [371] 0 0
Sweden
State/province [371] 0 0
Uppsala
Country [372] 0 0
Sweden
State/province [372] 0 0
Västerås
Country [373] 0 0
Switzerland
State/province [373] 0 0
Aarau
Country [374] 0 0
Switzerland
State/province [374] 0 0
Baden
Country [375] 0 0
Switzerland
State/province [375] 0 0
Basel
Country [376] 0 0
Switzerland
State/province [376] 0 0
Bern
Country [377] 0 0
Switzerland
State/province [377] 0 0
Chur
Country [378] 0 0
Switzerland
State/province [378] 0 0
Luzern
Country [379] 0 0
Switzerland
State/province [379] 0 0
St. Gallen
Country [380] 0 0
Switzerland
State/province [380] 0 0
Thun
Country [381] 0 0
Switzerland
State/province [381] 0 0
Winterthur
Country [382] 0 0
Switzerland
State/province [382] 0 0
Zürich
Country [383] 0 0
Taiwan
State/province [383] 0 0
Beitou Dist.
Country [384] 0 0
Taiwan
State/province [384] 0 0
Changhua County
Country [385] 0 0
Taiwan
State/province [385] 0 0
Hsinchu City
Country [386] 0 0
Taiwan
State/province [386] 0 0
Kaohsiung City
Country [387] 0 0
Taiwan
State/province [387] 0 0
New Taipei City
Country [388] 0 0
Taiwan
State/province [388] 0 0
Taichung
Country [389] 0 0
Taiwan
State/province [389] 0 0
Tainan
Country [390] 0 0
Taiwan
State/province [390] 0 0
Taipei City
Country [391] 0 0
Taiwan
State/province [391] 0 0
Taipei
Country [392] 0 0
Taiwan
State/province [392] 0 0
Taoyuan
Country [393] 0 0
Taiwan
State/province [393] 0 0
Xitun Dist.
Country [394] 0 0
Thailand
State/province [394] 0 0
Bangkok
Country [395] 0 0
Turkey
State/province [395] 0 0
Ankara
Country [396] 0 0
Turkey
State/province [396] 0 0
Antalya
Country [397] 0 0
Turkey
State/province [397] 0 0
Edirne
Country [398] 0 0
Turkey
State/province [398] 0 0
Istanbul
Country [399] 0 0
Turkey
State/province [399] 0 0
Izmir
Country [400] 0 0
Turkey
State/province [400] 0 0
Kocaeli
Country [401] 0 0
Turkey
State/province [401] 0 0
Samsun
Country [402] 0 0
Turkey
State/province [402] 0 0
Sariçam
Country [403] 0 0
Turkey
State/province [403] 0 0
Seyhan/Adana
Country [404] 0 0
Turkey
State/province [404] 0 0
Yen?mahalle
Country [405] 0 0
Turkey
State/province [405] 0 0
Üsküdar
Country [406] 0 0
Uganda
State/province [406] 0 0
Kampala
Country [407] 0 0
Ukraine
State/province [407] 0 0
Kharkiv Governorate
Country [408] 0 0
Ukraine
State/province [408] 0 0
Kherson Governorate
Country [409] 0 0
Ukraine
State/province [409] 0 0
KIEV Governorate
Country [410] 0 0
Ukraine
State/province [410] 0 0
Podolia Governorate
Country [411] 0 0
Ukraine
State/province [411] 0 0
Kyiv
Country [412] 0 0
United Kingdom
State/province [412] 0 0
Brighton
Country [413] 0 0
United Kingdom
State/province [413] 0 0
Leicester
Country [414] 0 0
United Kingdom
State/province [414] 0 0
London
Country [415] 0 0
United Kingdom
State/province [415] 0 0
Nottingham
Country [416] 0 0
United Kingdom
State/province [416] 0 0
Preston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GO42784 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
For eligible studies, qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT04961996