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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/NCT05059522
Registration number
NCT05059522
Ethics application status
Date submitted
17/09/2021
Date registered
28/09/2021
Date last updated
22/05/2024
Titles & IDs
Public title
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
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Scientific title
Avelumab Master Protocol: An Open-label Continuation Study for Participants Continuing From Pfizer-sponsored Avelumab Clinical Studies.
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Secondary ID [1]
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2021-002457-29
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Secondary ID [2]
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B9991046
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Malignancies
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NSCLC
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Ovarian Cancer
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Urothelial Cancer
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Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Avelumab
Treatment: Drugs - Lorlatanib
Treatment: Drugs - Talazoparib
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Axitinib
Treatment: Drugs - CMP 001
Treatment: Drugs - Utomilumab
Treatment: Drugs - PF04518600
Experimental: Arm 1 - Avelumab monotherapy as specified by sub-study protocol B9991001C
Experimental: Arm 2 - Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C
Experimental: Arm 3 - Avelumab in combination with Loratanib as specified by sub-study protocol B9991005C
Experimental: Arm 4 - Avelumab monotherapy as specified by sub-study protocol B9991009C
Experimental: Arm 5 - Avelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C
Experimental: Arm 6 - Avelumab in combination with Talazoparib as specified by sub-study B9991025C.
Experimental: Arm 7 - Avelumab in combination with Axitinib as specified by sub-study B9991027C.
Experimental: Arm 8 - Avelumab in combination with Talazoparib as specified by sub-study B9991032C.
Treatment: Drugs: Avelumab
oral
Treatment: Drugs: Lorlatanib
oral
Treatment: Drugs: Talazoparib
oral
Treatment: Drugs: Pemetrexed
IV (intravenous) infusion
Treatment: Drugs: Axitinib
oral
Treatment: Drugs: CMP 001
IT (intratumoral) or SC (subcutaneous)
Treatment: Drugs: Utomilumab
IV infusion
Treatment: Drugs: PF04518600
IV infusion
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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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Number of participants with adverse events leading to permanent discontinuation of study intervention
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Assessment method [1]
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Timepoint [1]
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Baseline up to approximately 5 years
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Primary outcome [2]
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Number serious adverse events reported for all participants
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Assessment method [2]
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Timepoint [2]
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Baseline up to approximately 5 years
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Eligibility
Key inclusion criteria
1. Any participant who is receiving study treatment and deriving significant clinical
benefit or is in the safety and/or survival follow-up period in a Pfizer-sponsored
Avelumab Parent Study.
2. Participants must agree to follow the reproductive criteria.
3. Participants must be willing and able to comply with all scheduled visits, treatment
plan, and other study procedures.
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Minimum age
18
Years
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Maximum age
No limit
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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
1. Female participants who are pregnant or breastfeeding.
2. Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the
participant from inclusion in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Active, not 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
29/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
62
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Macquarie University - North Ryde
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Recruitment hospital [2]
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Mater Hospital Sydney - Wollstonecraft
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Recruitment hospital [3]
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Melanoma Institute Australia - Wollstonecraft
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Recruitment hospital [4]
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The Prince Charles Hospital - Chermside
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Recruitment postcode(s) [1]
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2109 - North Ryde
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Recruitment postcode(s) [2]
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2060 - Wollstonecraft
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Recruitment postcode(s) [3]
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2065 - Wollstonecraft
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Recruitment postcode(s) [4]
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4032 - Chermside
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Recruitment outside Australia
Country [1]
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Florida
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United States of America
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New Jersey
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United States of America
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New York
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Pennsylvania
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United States of America
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Texas
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United States of America
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Washington
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Belgium
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Hainaut
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Belgium
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Canada
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Canada
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Ontario
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Denmark
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Nordjylland
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France
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Lorraine
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Hungary
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Budapest
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Israel
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Hamerkaz
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Italy
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Lombardia
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Italy
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Milano
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Italy
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Ancona
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Italy
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Roma
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Japan
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Tokyo
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Japan
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Fukuoka
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Japan
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Oita
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Korea, Republic of
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Incheon-gwangyeoksi [incheon]
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Seoul-teukbyeolsi [seoul]
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Mexico
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Nuevo LEÓN
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Mexico
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Oaxaca
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New Zealand
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Auckland
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Poland
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Warszawa
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Russian Federation
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Omskaya Oblast'
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Russian Federation
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Saint - Petersburg
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Russian Federation
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Stavropol'skiy KRAY
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Ufa
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Serbia
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Belgrade
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Spain
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Barcelona [barcelona]
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
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Kensington AND Chelsea
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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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 Master Protocol for Avelumab Continuation Sub-Studies is to provide continued treatment
access, safety follow-up, and when applicable, overall survival follow-up for eligible
participants who continue to derive a benefit from study intervention in the Pfizer-sponsored
Avelumab parent studies.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05059522
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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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Pfizer CT.gov Call Center
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Address
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Pfizer
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Phone
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Email
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Contact person for public queries
Name
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05059522
Download to PDF