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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04128696




Registration number
NCT04128696
Ethics application status
Date submitted
15/10/2019
Date registered
16/10/2019

Titles & IDs
Public title
Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Scientific title
A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Secondary ID [1] 0 0
2019-002263-99
Secondary ID [2] 0 0
209229
Universal Trial Number (UTN)
Trial acronym
INDUCE-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Head and Neck 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - feladilimab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Placebo

Experimental: Participants receiving feladilimab and pembrolizumab - Participants were administered feladilimab (humanized anti-ICOS immunoglobulin G4 \[IgG4\] monoclonal antibody \[mAb\]) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an intravenous (IV) infusion once every three weeks.

Active comparator: Participants receiving placebo and pembrolizumab - Participants were administered placebo and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion once every three weeks.


Treatment: Drugs: feladilimab
feladilimab is available as an intravenous infusion.

Treatment: Drugs: Pembrolizumab
Pembrolizumab is available as an intravenous infusion.

Treatment: Drugs: Placebo
Placebo is available as an intravenous infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in the Programmed Death Receptor-ligand 1 (PD-L1) Combined Positive Score (CPS) =1 Population
Timepoint [1] 0 0
Up to approximately 16 months
Primary outcome [2] 0 0
OS in the PD-L1 Expression High (CPS =20) Population
Timepoint [2] 0 0
Up to approximately 16 months
Primary outcome [3] 0 0
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) in the PD-L1 CPS =1 Population
Timepoint [3] 0 0
Up to approximately 16 months
Secondary outcome [1] 0 0
PFS Per Immune-based RECIST (iRECIST) in the PD-L1 CPS =1 Population
Timepoint [1] 0 0
Up to approximately 16 months
Secondary outcome [2] 0 0
PFS Per RECIST in the PD-L1 CPS =20 Population
Timepoint [2] 0 0
Up to approximately 16 months
Secondary outcome [3] 0 0
PFS Per iRECIST (iPFS) in the PD-L1 CPS =20 Population
Timepoint [3] 0 0
Up to approximately 16 months
Secondary outcome [4] 0 0
Milestone OS Rate at 12 Months in the PD-L1 CPS =1 Population
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Milestone OS Rate at 24 Months in the PD-L1 CPS =1 Population
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Milestone OS Rate at 12 Months in the PD-L1 CPS =20 Population
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Milestone OS Rate at 24 Months in the PD-L1 CPS =20 Population
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Overall Response Rate (ORR) Per RECIST v1.1 in the PD-L1 CPS =1 Population
Timepoint [8] 0 0
Up to approximately 16 months
Secondary outcome [9] 0 0
ORR Per RECIST v1.1 in the PD-L1 CPS =20 Population
Timepoint [9] 0 0
Up to approximately 16 months
Secondary outcome [10] 0 0
Disease Control Rate (DCR) Per RECIST v1.1 in the PD-L1 CPS =1 Population
Timepoint [10] 0 0
Up to approximately 16 months
Secondary outcome [11] 0 0
DCR Per RECIST v1.1 in the PD-L1 CPS =20 Population
Timepoint [11] 0 0
Up to approximately 16 months
Secondary outcome [12] 0 0
Duration of Response (DoR) Per RECIST v1.1 in the PD-L1 CPS =1 Population
Timepoint [12] 0 0
Up to approximately 16 months
Secondary outcome [13] 0 0
DoR Per RECIST v1.1 in the PD-L1 CPS =20 Population
Timepoint [13] 0 0
Up to approximately 16 months
Secondary outcome [14] 0 0
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [14] 0 0
Up to approximately 43 months
Secondary outcome [15] 0 0
Number of Participants With AEs by Severity
Timepoint [15] 0 0
Up to approximately 43 months
Secondary outcome [16] 0 0
Number of Participants With SAEs by Severity
Timepoint [16] 0 0
Up to approximately 43 months
Secondary outcome [17] 0 0
Number of Participants With Adverse Events of Special Interest (AESI)
Timepoint [17] 0 0
Up to approximately 43 months
Secondary outcome [18] 0 0
Number of Participants With AESI by Severity
Timepoint [18] 0 0
Up to approximately 43 months
Secondary outcome [19] 0 0
Number of Participants With Dose Modifications
Timepoint [19] 0 0
Up to approximately 16 months
Secondary outcome [20] 0 0
Time to Deterioration (TTD) in Pain in the PD-L1 CPS =1 Population
Timepoint [20] 0 0
Up to approximately 16 months
Secondary outcome [21] 0 0
TTD in Pain in the PD-L1 CPS =20 Population
Timepoint [21] 0 0
Up to approximately 16 months
Secondary outcome [22] 0 0
TTD in Physical Function in the PD-L1 CPS =1 Population
Timepoint [22] 0 0
Up to approximately 16 months
Secondary outcome [23] 0 0
TTD in Physical Function in the PD-L1 CPS =20 Population
Timepoint [23] 0 0
Up to approximately 16 months

Eligibility
Key inclusion criteria
* Capable of giving signed informed consent
* Male or female, age >=18 years
* Histological or cytological documentation of Head and Neck Squamous Cell Carcinoma (HNSCC) that is considered incurable by local therapies
* Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx
* No prior systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy given as part of multimodal treatment for locally advanced disease)
* Measurable disease per RECIST version 1.1 guidelines
* ECOG Performance PS score of 0 or 1
* Adequate organ function
* Life expectancy of at least 12 weeks
* Female participants: must not be pregnant, not breastfeeding, and at least one of the following conditions apply:

1. Not a woman of childbearing potential (WOCBP)
2. A WOCBP who agrees to use a method of birth control from 30 days prior to randomization and for at least 120 days after the last dose of study treatment
* Male participants with female partners of child-bearing potential: must agree to use a highly effective contraception while receiving study treatment and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period
* Provide tumor tissue from excisional or core biopsy (fine needle aspirates and bone biopsies are not acceptable) acquired within 2 years prior to randomization for PD-L1 immunohistochemistry (IHC) testing by central laboratory
* Have PD-L1 Immunohistochemistry (IHC) CPS 1 status by central laboratory testing
* Have results from testing of Human Papilloma Virus (HPV) status for oropharyngeal cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent
* Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter
* Major surgery 28 days prior to randomization
* Has high risk of bleeding
* Toxicity related to prior treatment that has not resolved to <=Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be<= Grade 2)
* Received transfusion of blood products or administration of colony stimulating factors within 14 days prior to randomization
* Central nervous system (CNS) metastases, with the following exception: Participants with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to randomization
* Invasive malignancy or history of invasive malignancy other than disease under study within the last 3 years, except as noted below:

a. Any other invasive malignancy for which the participant was definitively treated, has been disease-free for 3 years and in the opinion of the principal investigator and GSK Medical Monitor will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy, may be included in this clinical study
* Autoimmune disease or syndrome that required systemic treatment within the past 2 years
* Has a diagnosis of immunodeficiency or is receiving systemic steroids (=10 mg oral prednisone per day or equivalent) or other immunosuppressive agents within 7 days prior to randomization
* Receipt of any live vaccine within 30 days prior randomization
* Prior allogeneic/autologous bone marrow or solid organ transplantation
* Has current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents
* Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions
* Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess
* Recent history of allergen desensitization therapy within 4 weeks of randomization
* History or evidence of cardiac abnormalities within the 6 months prior to randomization
* Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice
* Active infection requiring systemic therapy
* Known HIV infection, or positive test for hepatitis B active infection (presence of hepatitis B surface antigen), or hepatitis C active infection
* History of severe hypersensitivity to monoclonal antibodies or any ingredient used in the study treatment formulations
* Known history of active tuberculosis
* Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator
* Is currently participating in (unless in follow-up phase and 4 weeks have elapsed from last dose of prior investigational agent), or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to date of randomization
* Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/06/2023
Sample size
Target
Accrual to date
Final
315
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Blacktown
Recruitment hospital [2] 0 0
GSK Investigational Site - St Leonards
Recruitment hospital [3] 0 0
GSK Investigational Site - Herston
Recruitment hospital [4] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [5] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [6] 0 0
GSK Investigational Site - Nedlands
Recruitment hospital [7] 0 0
GSK Investigational Site - Darlinghurst
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Argentina
State/province [12] 0 0
Ciudad Autónoma de Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
San Juan
Country [14] 0 0
Brazil
State/province [14] 0 0
Espírito Santo
Country [15] 0 0
Brazil
State/province [15] 0 0
Santa Catarina
Country [16] 0 0
Brazil
State/province [16] 0 0
São Paulo
Country [17] 0 0
Brazil
State/province [17] 0 0
Belo Horizonte, Minas Gerais
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
China
State/province [22] 0 0
Guangdong
Country [23] 0 0
China
State/province [23] 0 0
Guangxi
Country [24] 0 0
China
State/province [24] 0 0
Guizhou
Country [25] 0 0
China
State/province [25] 0 0
Hubei
Country [26] 0 0
China
State/province [26] 0 0
Jiangxi
Country [27] 0 0
China
State/province [27] 0 0
Sichuan
Country [28] 0 0
China
State/province [28] 0 0
Bengbu
Country [29] 0 0
China
State/province [29] 0 0
Harbin
Country [30] 0 0
China
State/province [30] 0 0
Hefei
Country [31] 0 0
China
State/province [31] 0 0
Shnghai
Country [32] 0 0
Denmark
State/province [32] 0 0
Copenhagen
Country [33] 0 0
France
State/province [33] 0 0
Bordeaux
Country [34] 0 0
France
State/province [34] 0 0
Epagny Metz-Tessy
Country [35] 0 0
France
State/province [35] 0 0
Le Mans
Country [36] 0 0
France
State/province [36] 0 0
Lille
Country [37] 0 0
France
State/province [37] 0 0
Lyon cedex 08
Country [38] 0 0
France
State/province [38] 0 0
Paris
Country [39] 0 0
France
State/province [39] 0 0
Saint Herblain cedex
Country [40] 0 0
France
State/province [40] 0 0
Strasbourg
Country [41] 0 0
France
State/province [41] 0 0
Toulouse Cedex 9
Country [42] 0 0
France
State/province [42] 0 0
Valenciennes Cedex
Country [43] 0 0
Germany
State/province [43] 0 0
Baden-Wuerttemberg
Country [44] 0 0
Germany
State/province [44] 0 0
Nordrhein-Westfalen
Country [45] 0 0
Germany
State/province [45] 0 0
Sachsen
Country [46] 0 0
Germany
State/province [46] 0 0
Berlin
Country [47] 0 0
Germany
State/province [47] 0 0
Hamburg
Country [48] 0 0
Greece
State/province [48] 0 0
Heraklion,Crete
Country [49] 0 0
Greece
State/province [49] 0 0
Thessaloniki
Country [50] 0 0
Ireland
State/province [50] 0 0
Dublin
Country [51] 0 0
Israel
State/province [51] 0 0
Jerusalem
Country [52] 0 0
Israel
State/province [52] 0 0
Petah Tikva
Country [53] 0 0
Israel
State/province [53] 0 0
Ramat Gan
Country [54] 0 0
Italy
State/province [54] 0 0
Emilia-Romagna
Country [55] 0 0
Italy
State/province [55] 0 0
Lombardia
Country [56] 0 0
Italy
State/province [56] 0 0
Piemonte
Country [57] 0 0
Italy
State/province [57] 0 0
Veneto
Country [58] 0 0
Japan
State/province [58] 0 0
Chiba
Country [59] 0 0
Japan
State/province [59] 0 0
Ehime
Country [60] 0 0
Japan
State/province [60] 0 0
Fukuoka
Country [61] 0 0
Japan
State/province [61] 0 0
Hokkaido
Country [62] 0 0
Japan
State/province [62] 0 0
Hyogo
Country [63] 0 0
Japan
State/province [63] 0 0
Ibaraki
Country [64] 0 0
Japan
State/province [64] 0 0
Iwate
Country [65] 0 0
Japan
State/province [65] 0 0
Kagawa
Country [66] 0 0
Japan
State/province [66] 0 0
Kanagawa
Country [67] 0 0
Japan
State/province [67] 0 0
Miyagi
Country [68] 0 0
Japan
State/province [68] 0 0
Niigata
Country [69] 0 0
Japan
State/province [69] 0 0
Osaka
Country [70] 0 0
Japan
State/province [70] 0 0
Saitama
Country [71] 0 0
Japan
State/province [71] 0 0
Shizuoka
Country [72] 0 0
Japan
State/province [72] 0 0
Tokyo
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Busan
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Hwasun,Jeollanam-do
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Incheon
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Seongnam-si, Gyeonggi-do
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Seoul,
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Seoul
Country [79] 0 0
Mexico
State/province [79] 0 0
Coahuila
Country [80] 0 0
Mexico
State/province [80] 0 0
Jalisco
Country [81] 0 0
Netherlands
State/province [81] 0 0
Maastricht
Country [82] 0 0
Netherlands
State/province [82] 0 0
Rotterdam
Country [83] 0 0
Norway
State/province [83] 0 0
Bergen
Country [84] 0 0
Norway
State/province [84] 0 0
Oslo
Country [85] 0 0
Poland
State/province [85] 0 0
Bydgoszcz
Country [86] 0 0
Poland
State/province [86] 0 0
Gdynia
Country [87] 0 0
Poland
State/province [87] 0 0
Gliwice
Country [88] 0 0
Poland
State/province [88] 0 0
Krakow
Country [89] 0 0
Poland
State/province [89] 0 0
Olsztyn
Country [90] 0 0
Poland
State/province [90] 0 0
Tomaszow Mazowiecki
Country [91] 0 0
Poland
State/province [91] 0 0
Warszawa
Country [92] 0 0
Portugal
State/province [92] 0 0
Coimbra
Country [93] 0 0
Portugal
State/province [93] 0 0
Lisboa
Country [94] 0 0
Portugal
State/province [94] 0 0
Matosinhos
Country [95] 0 0
Portugal
State/province [95] 0 0
Porto
Country [96] 0 0
Romania
State/province [96] 0 0
Brasov
Country [97] 0 0
Romania
State/province [97] 0 0
Bucuresti
Country [98] 0 0
Romania
State/province [98] 0 0
Cluj Napoca
Country [99] 0 0
Romania
State/province [99] 0 0
Cluj-Napoca
Country [100] 0 0
Romania
State/province [100] 0 0
Constanta
Country [101] 0 0
Romania
State/province [101] 0 0
Craiova
Country [102] 0 0
Romania
State/province [102] 0 0
Floresti
Country [103] 0 0
Romania
State/province [103] 0 0
Iasi
Country [104] 0 0
Romania
State/province [104] 0 0
Oradea
Country [105] 0 0
Romania
State/province [105] 0 0
Otopeni
Country [106] 0 0
Romania
State/province [106] 0 0
Satu Mare
Country [107] 0 0
Romania
State/province [107] 0 0
Suceava
Country [108] 0 0
Russian Federation
State/province [108] 0 0
Moscow
Country [109] 0 0
Russian Federation
State/province [109] 0 0
Poselok Kuzmolovsky
Country [110] 0 0
Russian Federation
State/province [110] 0 0
Pushkin
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Saint-Petersburg
Country [112] 0 0
Russian Federation
State/province [112] 0 0
St. Petersburg
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Yaroslavl
Country [114] 0 0
Spain
State/province [114] 0 0
Barcelona
Country [115] 0 0
Spain
State/province [115] 0 0
Madrid
Country [116] 0 0
Spain
State/province [116] 0 0
Málaga
Country [117] 0 0
Spain
State/province [117] 0 0
Pozuelo De Alarcón/Madrid
Country [118] 0 0
Spain
State/province [118] 0 0
Santiago de Compostela
Country [119] 0 0
Spain
State/province [119] 0 0
Valencia
Country [120] 0 0
Spain
State/province [120] 0 0
Zaragoza
Country [121] 0 0
Switzerland
State/province [121] 0 0
St Gallen
Country [122] 0 0
Switzerland
State/province [122] 0 0
Zuerich
Country [123] 0 0
Taiwan
State/province [123] 0 0
Changhua
Country [124] 0 0
Taiwan
State/province [124] 0 0
Kaohsiung City
Country [125] 0 0
Taiwan
State/province [125] 0 0
Taipei
Country [126] 0 0
Taiwan
State/province [126] 0 0
Taoyuan City
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Lancashire
Country [128] 0 0
United Kingdom
State/province [128] 0 0
London
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Nottingham
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a data sharing agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04128696