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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05514054




Registration number
NCT05514054
Ethics application status
Date submitted
23/08/2022
Date registered
24/08/2022

Titles & IDs
Public title
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
Scientific title
EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence
Secondary ID [1] 0 0
J2J-MC-JZLH
Secondary ID [2] 0 0
18459
Universal Trial Number (UTN)
Trial acronym
EMBER-4
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Imlunestrant
Treatment: Drugs - Tamoxifen
Treatment: Drugs - Anastrozole
Treatment: Drugs - Letrozole
Treatment: Drugs - Exemestane

Experimental: Imlunestrant - Imlunestrant administered orally.

Active comparator: Investigator's Choice of Endocrine Therapy - Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label.


Treatment: Drugs: Imlunestrant
Administered orally.

Treatment: Drugs: Tamoxifen
Administered per local approved label.

Treatment: Drugs: Anastrozole
Administered per local approved label.

Treatment: Drugs: Letrozole
Administered per local approved label.

Treatment: Drugs: Exemestane
Administered per local approved label.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Disease-Free Survival (IDFS)
Timepoint [1] 0 0
Randomization to recurrence or death from any cause (up to 10 years)
Secondary outcome [1] 0 0
Distant Recurrence-Free Survival (DRFS)
Timepoint [1] 0 0
Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Randomization to Death from Any Cause (up to 10 Years)
Secondary outcome [3] 0 0
Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant
Timepoint [3] 0 0
Year 1, Month 2 to Month 4
Secondary outcome [4] 0 0
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning
Timepoint [4] 0 0
Visit 1 Day 1 up to end of Year 5
Secondary outcome [5] 0 0
Change from Baseline in the EORTC QLQ-C30 Role Functioning
Timepoint [5] 0 0
Visit 1 Day 1 up to end of Year 5
Secondary outcome [6] 0 0
Change from Baseline in the EORTC QLQ-C30 Global QOL
Timepoint [6] 0 0
Visit 1 Day 1 up to end of Year 5
Secondary outcome [7] 0 0
Proportion of Time on Study Treatment with High Overall Adverse Event Burden
Timepoint [7] 0 0
Visit 1 Day 1 up to end of Year 5

Eligibility
Key inclusion criteria
* Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
* Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
* Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
* Must have an increased risk of disease recurrence based on clinical-pathological risk features.
* Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
* Have adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
* Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
* Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening.
* Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone =5 years ago.
* Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
* Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
* Participants with a history of any other cancer.
* Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.

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
4/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2032
Actual
Sample size
Target
6000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Coffs Harbour Health Campus - Coffs Harbour
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St Vincent's Hospital - Darlinghurst
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Gosford Hospital - Gosford
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Liverpool Hospital - Liverpool
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Lake Macquarie Private Hospital - Newcastle
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Mater Hospital Sydney - Sydney
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Royal Darwin Hospital - Tiwi
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Mackay Base Hospital - Mackay
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Gold Coast University Hospital - Southport
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The Townsville Hospital - Townsville
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Hervey Bay Hospital - Urraween
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The Queen Elizabeth Hospital - Woodville
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Royal Hobart Hospital - Hobart
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Launceston General Hospital - Launceston
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Ballarat Health Services - Ballarat Central
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Box Hill Hospital - Box Hill
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Monash Health - Clayton
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Barwon Health - Geelong
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St Vincent's Hospital - Melbourne
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Northern Hospital - Melbourne
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Maroondah Hospital - Melbourne
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Goulburn Valley Health - Shepparton
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Breast Cancer Research Centre-WA - Nedlands
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
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2010 - Darlinghurst
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2250 - Gosford
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2170 - Liverpool
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2290 - Newcastle
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2060 - Sydney
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0810 - Tiwi
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4740 - Mackay
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4215 - Southport
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4814 - Townsville
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4655 - Urraween
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5011 - Woodville
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7000 - Hobart
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7250 - Launceston
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3350 - Ballarat Central
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3128 - Box Hill
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3168 - Clayton
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3220 - Geelong
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3065 - Melbourne
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3076 - Melbourne
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3135 - Melbourne
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3630 - Shepparton
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6009 - Nedlands
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Italy
State/province [193] 0 0
Padova
Country [194] 0 0
Italy
State/province [194] 0 0
Parma
Country [195] 0 0
Italy
State/province [195] 0 0
Terni
Country [196] 0 0
Japan
State/province [196] 0 0
Aichi
Country [197] 0 0
Japan
State/province [197] 0 0
Chiba
Country [198] 0 0
Japan
State/province [198] 0 0
Ehime
Country [199] 0 0
Japan
State/province [199] 0 0
Gunma
Country [200] 0 0
Japan
State/province [200] 0 0
Hiroshima
Country [201] 0 0
Japan
State/province [201] 0 0
Hokkaido
Country [202] 0 0
Japan
State/province [202] 0 0
Hyogo
Country [203] 0 0
Japan
State/province [203] 0 0
Ibaraki
Country [204] 0 0
Japan
State/province [204] 0 0
Ishikawa
Country [205] 0 0
Japan
State/province [205] 0 0
Iwate
Country [206] 0 0
Japan
State/province [206] 0 0
Kanagawa
Country [207] 0 0
Japan
State/province [207] 0 0
Miyagi
Country [208] 0 0
Japan
State/province [208] 0 0
Nagano
Country [209] 0 0
Japan
State/province [209] 0 0
Niigata
Country [210] 0 0
Japan
State/province [210] 0 0
Okinawa
Country [211] 0 0
Japan
State/province [211] 0 0
Osaka
Country [212] 0 0
Japan
State/province [212] 0 0
Shimane
Country [213] 0 0
Japan
State/province [213] 0 0
Tochigi
Country [214] 0 0
Japan
State/province [214] 0 0
Tokyo
Country [215] 0 0
Japan
State/province [215] 0 0
Fukuoka
Country [216] 0 0
Japan
State/province [216] 0 0
Fukushima
Country [217] 0 0
Japan
State/province [217] 0 0
Gifu
Country [218] 0 0
Japan
State/province [218] 0 0
Kagoshima
Country [219] 0 0
Japan
State/province [219] 0 0
Kumamoto
Country [220] 0 0
Japan
State/province [220] 0 0
Kyoto
Country [221] 0 0
Japan
State/province [221] 0 0
Miyazaki
Country [222] 0 0
Japan
State/province [222] 0 0
Okayama
Country [223] 0 0
Japan
State/province [223] 0 0
Saitama
Country [224] 0 0
Japan
State/province [224] 0 0
Shizuoka
Country [225] 0 0
Japan
State/province [225] 0 0
Tokushima
Country [226] 0 0
Korea, Republic of
State/province [226] 0 0
Chungcheongbuk-do [Chungbuk]
Country [227] 0 0
Korea, Republic of
State/province [227] 0 0
Chungcheongnam-do [Chungnam]
Country [228] 0 0
Korea, Republic of
State/province [228] 0 0
Incheon-gwangyeoksi [Incheon]
Country [229] 0 0
Korea, Republic of
State/province [229] 0 0
Jeonranamdo
Country [230] 0 0
Korea, Republic of
State/province [230] 0 0
Kyonggi-do
Country [231] 0 0
Korea, Republic of
State/province [231] 0 0
Kyongsangbuk-do
Country [232] 0 0
Korea, Republic of
State/province [232] 0 0
Pusan-Kwangyokshi
Country [233] 0 0
Korea, Republic of
State/province [233] 0 0
Seoul-teukbyeolsi [Seoul]
Country [234] 0 0
Korea, Republic of
State/province [234] 0 0
Taegu-Kwangyokshi
Country [235] 0 0
Korea, Republic of
State/province [235] 0 0
Ulsan-Kwangyokshi
Country [236] 0 0
Mexico
State/province [236] 0 0
Baja California
Country [237] 0 0
Mexico
State/province [237] 0 0
Chiapas
Country [238] 0 0
Mexico
State/province [238] 0 0
Distrito Federal
Country [239] 0 0
Mexico
State/province [239] 0 0
Guanajuato
Country [240] 0 0
Mexico
State/province [240] 0 0
Jalisco
Country [241] 0 0
Mexico
State/province [241] 0 0
Nuevo León
Country [242] 0 0
Mexico
State/province [242] 0 0
San Luis Potosí
Country [243] 0 0
Mexico
State/province [243] 0 0
Tamaulipas
Country [244] 0 0
Mexico
State/province [244] 0 0
Chihuahua
Country [245] 0 0
Mexico
State/province [245] 0 0
Oaxaca
Country [246] 0 0
Mexico
State/province [246] 0 0
Puebla
Country [247] 0 0
Mexico
State/province [247] 0 0
Querétaro
Country [248] 0 0
Mexico
State/province [248] 0 0
Toluca
Country [249] 0 0
Netherlands
State/province [249] 0 0
Drenthe
Country [250] 0 0
Netherlands
State/province [250] 0 0
Limburg
Country [251] 0 0
Netherlands
State/province [251] 0 0
Noord-Brabant
Country [252] 0 0
Netherlands
State/province [252] 0 0
Noord-Holland
Country [253] 0 0
Netherlands
State/province [253] 0 0
Overijssel
Country [254] 0 0
Netherlands
State/province [254] 0 0
Zuid-Holland
Country [255] 0 0
Poland
State/province [255] 0 0
Kujawsko-pomorskie
Country [256] 0 0
Poland
State/province [256] 0 0
Mazowieckie
Country [257] 0 0
Poland
State/province [257] 0 0
Malopolskie
Country [258] 0 0
Poland
State/province [258] 0 0
Opolskie
Country [259] 0 0
Poland
State/province [259] 0 0
Pomorskie
Country [260] 0 0
Poland
State/province [260] 0 0
Zachodniopomorskie
Country [261] 0 0
Poland
State/province [261] 0 0
Lódzkie
Country [262] 0 0
Portugal
State/province [262] 0 0
Lisboa
Country [263] 0 0
Portugal
State/province [263] 0 0
Porto
Country [264] 0 0
Portugal
State/province [264] 0 0
Setúbal
Country [265] 0 0
Romania
State/province [265] 0 0
Bra?ov
Country [266] 0 0
Romania
State/province [266] 0 0
Bucure?ti
Country [267] 0 0
Romania
State/province [267] 0 0
Cluj
Country [268] 0 0
Romania
State/province [268] 0 0
Constan?a
Country [269] 0 0
Romania
State/province [269] 0 0
Dolj
Country [270] 0 0
Romania
State/province [270] 0 0
Ilfov
Country [271] 0 0
Romania
State/province [271] 0 0
Timi?
Country [272] 0 0
Singapore
State/province [272] 0 0
Central Singapore
Country [273] 0 0
Slovakia
State/province [273] 0 0
Bratislavský Kraj
Country [274] 0 0
Spain
State/province [274] 0 0
A Coruña [La Coruña]
Country [275] 0 0
Spain
State/province [275] 0 0
Andalucía
Country [276] 0 0
Spain
State/province [276] 0 0
Balears [Baleares]
Country [277] 0 0
Spain
State/province [277] 0 0
Barcelona [Barcelona]
Country [278] 0 0
Spain
State/province [278] 0 0
Catalunya [Cataluña]
Country [279] 0 0
Spain
State/province [279] 0 0
Extremadura
Country [280] 0 0
Spain
State/province [280] 0 0
Jaén
Country [281] 0 0
Spain
State/province [281] 0 0
La Rioja
Country [282] 0 0
Spain
State/province [282] 0 0
Lleida [Lérida]
Country [283] 0 0
Spain
State/province [283] 0 0
Lugo [Lugo]
Country [284] 0 0
Spain
State/province [284] 0 0
Madrid, Comunidad De
Country [285] 0 0
Spain
State/province [285] 0 0
Murcia, Región De
Country [286] 0 0
Spain
State/province [286] 0 0
Málaga
Country [287] 0 0
Spain
State/province [287] 0 0
Navarra
Country [288] 0 0
Spain
State/province [288] 0 0
País Vasco
Country [289] 0 0
Spain
State/province [289] 0 0
Santa Cruz De Tenerife
Country [290] 0 0
Spain
State/province [290] 0 0
Tarragona [Tarragona]
Country [291] 0 0
Spain
State/province [291] 0 0
Valenciana, Comunitat
Country [292] 0 0
Spain
State/province [292] 0 0
València
Country [293] 0 0
Spain
State/province [293] 0 0
Alicante
Country [294] 0 0
Spain
State/province [294] 0 0
Badajoz
Country [295] 0 0
Spain
State/province [295] 0 0
Burgos
Country [296] 0 0
Spain
State/province [296] 0 0
Granada
Country [297] 0 0
Spain
State/province [297] 0 0
Madrid
Country [298] 0 0
Spain
State/province [298] 0 0
Santa Cruz de Tenerife
Country [299] 0 0
Spain
State/province [299] 0 0
Segovia
Country [300] 0 0
Spain
State/province [300] 0 0
Sevilla
Country [301] 0 0
Spain
State/province [301] 0 0
Toledo
Country [302] 0 0
Spain
State/province [302] 0 0
Valladolid
Country [303] 0 0
Spain
State/province [303] 0 0
Zaragoza
Country [304] 0 0
Taiwan
State/province [304] 0 0
Changhua
Country [305] 0 0
Taiwan
State/province [305] 0 0
Tainan
Country [306] 0 0
Taiwan
State/province [306] 0 0
Kaohsiung
Country [307] 0 0
Taiwan
State/province [307] 0 0
New Taipei City
Country [308] 0 0
Taiwan
State/province [308] 0 0
Taichung
Country [309] 0 0
Taiwan
State/province [309] 0 0
Taipei
Country [310] 0 0
Taiwan
State/province [310] 0 0
Taoyuan
Country [311] 0 0
Turkey
State/province [311] 0 0
Ankara
Country [312] 0 0
Turkey
State/province [312] 0 0
Istanbul
Country [313] 0 0
Turkey
State/province [313] 0 0
Izmir
Country [314] 0 0
Turkey
State/province [314] 0 0
Mugla
Country [315] 0 0
Turkey
State/province [315] 0 0
Sakarya
Country [316] 0 0
Turkey
State/province [316] 0 0
Adana
Country [317] 0 0
Turkey
State/province [317] 0 0
Antalya
Country [318] 0 0
Turkey
State/province [318] 0 0
Bursa
Country [319] 0 0
Turkey
State/province [319] 0 0
Diyarbakir
Country [320] 0 0
Turkey
State/province [320] 0 0
Edirne
Country [321] 0 0
Turkey
State/province [321] 0 0
Gaziantep
Country [322] 0 0
Turkey
State/province [322] 0 0
Kocaeli
Country [323] 0 0
Turkey
State/province [323] 0 0
Malatya
Country [324] 0 0
Turkey
State/province [324] 0 0
Mersin
Country [325] 0 0
Turkey
State/province [325] 0 0
Samsun
Country [326] 0 0
United Kingdom
State/province [326] 0 0
Devon
Country [327] 0 0
United Kingdom
State/province [327] 0 0
England
Country [328] 0 0
United Kingdom
State/province [328] 0 0
Essex
Country [329] 0 0
United Kingdom
State/province [329] 0 0
Great Britain
Country [330] 0 0
United Kingdom
State/province [330] 0 0
Hertfordshire
Country [331] 0 0
United Kingdom
State/province [331] 0 0
London, City Of
Country [332] 0 0
United Kingdom
State/province [332] 0 0
Manchester
Country [333] 0 0
United Kingdom
State/province [333] 0 0
Midlothian
Country [334] 0 0
United Kingdom
State/province [334] 0 0
Liverpool
Country [335] 0 0
United Kingdom
State/province [335] 0 0
Reading

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
ClinicalTrials.gov@lilly.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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/NCT05514054