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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/NCT06049017
Registration number
NCT06049017
Ethics application status
Date submitted
15/09/2023
Date registered
21/09/2023
Date last updated
23/05/2024
Titles & IDs
Public title
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
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Scientific title
A Phase 2b Multicenter, Randomized, Placebo- Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderately to Severely Active Ulcerative Colitis
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Secondary ID [1]
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77242113UCO2001
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Secondary ID [2]
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77242113UCO2001
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Universal Trial Number (UTN)
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Trial acronym
ANTHEM-UC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-77242113
Treatment: Drugs - Placebo
Experimental: Group 1: JNJ-77242113 Dose-1 - Participants will receive JNJ-77242113 Dose-1 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.
Experimental: Group 2: JNJ-77242113 Dose-2 - Participants will receive JNJ-77242113 Dose-2 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.
Experimental: Group 3: JNJ-77242113 Dose-3 - Participants will receive JNJ-77242113 Dose-3 tablets orally from Week 0 through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week LTE period and receive the same treatment up to Week 76.
Experimental: Group 4: Placebo - Participants will receive placebo tablets orally from Week 0 through Week 28. Placebo-treated participants who meet the criteria of inadequate response at Week 16, will receive JNJ-77242113 Dose-3 tablet orally through Week 28. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention, will continue in the 48-week LTE period and receive the same treatment up to Week 76.
Treatment: Drugs: JNJ-77242113
JNJ-77242113 tablet will be administered orally.
Treatment: Drugs: Placebo
Placebo tablet will be administered orally.
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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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Percentage of Participants with Clinical Response at Week 12
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Assessment method [1]
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Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Percentage of Participants with Clinical Remission at Week 12
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Assessment method [1]
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Clinical remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Percentage of Participants with Symptomatic Remission at Week 12
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Assessment method [2]
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Symptomatic remission is defined as stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, and a rectal bleeding subscore of 0.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Percentage of Participants with Endoscopic Improvement at Week 12
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Assessment method [3]
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Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Percentage of Participants with Histologic-endoscopic Mucosal Improvement at Week 12
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Assessment method [4]
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Histologic-endoscopic mucosal improvement is defined as a combination of histologic remission and endoscopic improvement. Histologic remission and endoscopic improvement are based on the histologic grading and the Mayo endoscopy subscore.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Percentage of Participants with Adverse Events (AE) and Serious Adverse Evets (SAEs)
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Assessment method [5]
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
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Timepoint [5]
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Up to Week 76
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Eligibility
Key inclusion criteria
- Signed informed consent form 18 years of age or older
- Documented diagnosis of ulcerative colitis (UC) of at least 12 weeks prior to
screening
- Moderately to severely active UC as per the modified Mayo score
- Demonstrated inadequate response to or intolerance of conventional therapy and/or
advanced therapy as defined in the protocol
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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
- Participants with current or prior diagnosis of fulminant colitis and/or toxic
megacolon
- UC limited to rectum only or to less than (<) 15 centimeters (cm) of colon
- Presence of a stoma
- Presence or history of fistula
- History of extensive colonic resection (example, <30 cm of colon remaining)
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's
colitis or clinical findings suggestive of Crohn's disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
9/10/2023
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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
16/01/2026
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Actual
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Sample size
Target
240
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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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Sunshine Coast University Hospital - Birtinya
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Blacktown Hospital - Blacktown
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Concord Repatriation General Hospital - Concord
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Wollongong Private Hospital - Wollongong
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4575 - Birtinya
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2148 - Blacktown
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2139 - Concord
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Recruitment postcode(s) [4]
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2500 - Wollongong
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Recruitment outside Australia
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Spain
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State/province [122]
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Valencia
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Country [123]
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Spain
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State/province [123]
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Vigo
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Country [124]
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Turkey
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State/province [124]
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Ankara
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Country [125]
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Turkey
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State/province [125]
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Bursa
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Country [126]
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Turkey
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State/province [126]
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Izmir
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Country [127]
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Turkey
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State/province [127]
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Mersin
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Country [128]
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United Kingdom
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State/province [128]
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Bury
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Country [129]
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United Kingdom
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State/province [129]
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Cambridge
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United Kingdom
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London
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Country [131]
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United Kingdom
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Oxford
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Country [132]
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United Kingdom
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State/province [132]
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Prescot
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Country [133]
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United Kingdom
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State/province [133]
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113
compared with placebo in participants with moderately to severely active ulcerative colitis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06049017
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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0
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Email
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Contact person for public queries
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Study Contact
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Address
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0
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0
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Phone
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844-434-4210
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Email
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[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/NCT06049017
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