CompletedNCT05180240ARCHERUpdated Sep 30, 2026Results posted

Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

A Phase 2 interventional study of CardiolRx in Acute Myocarditis, sponsored by Cardiol Therapeutics Inc.. Completed at 37 sites in 5 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Cardiol Therapeutics Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 109
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis will be screened and, if eligible, randomized within 10 days of the diagnostic CMR to CardiolRx or placebo.

CardiolRx is pharmaceutically produced Cannabidiol and is free of tetrahydrocannabinol (THC\<5 ppm). The treatment period is 12 weeks; a last follow-up visit is scheduled one week after the last treatment, 13 weeks after randomization. Study assessments include Cardiac Magnetic Resonance imaging (CMR), ECG monitoring, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as physical exams and laboratory tests.

The primary and secondary outcome parameters are measured by CMR. Additional outcomes include clinical endpoints and changes in inflammatory and biomarkers.

Read the detailed description

Rationale:

Myocarditis is an acute inflammatory condition of the myocardium. Presentation of the disease may be fulminant and necessitate cardiac support, or even result in sudden cardiac death; milder cases are usually self-limiting but may progress to dilated cardiomyopathy with eventual end-stage heart failure. Other than treatments for associated heart failure there are no specific indicated treatments for myocarditis. CardiolRxTM (cannabidiol [CBD] solution), which is known to have anti-inflammatory properties, is being investigated to treat the underlying inflammatory process and thereby favorably modify acute myocarditis. The primary endpoints of the trial are cardiac magnetic resonance measures of left ventricular systolic function (ejection fraction and longitudinal strain) and myocardial edema (extra cellular volume) which have been shown to predict long term prognosis of patients with acute myocarditis.

Multi-center, double-blind, randomized, placebo-controlled, parallel group design. 1:1 randomization; treatment will be stratified within sites.

Patients diagnosed with acute myocarditis by a biopsy or a CMR will be screened within 10 days of the diagnostic CMR. Informed consent will be obtained at this point. For patients who have been diagnosed using an EMB, a CMR needs to be performed as well, which will be included in the informed consent form (ICF).Eligible patients will then be randomized within 10 days from the CMR assessment.

Baseline assessments include the following: Clinical assessment, including vital signs, ECG, 24-hr Holter, chest x-ray; Hematology and blood chemistry, NYHA classification, C SSRS and KCCQ. Frozen plasma will be retained for central analysis of hs-troponin, NT-proBNP and inflammatory markers.

Study treatment needs to be taken with food and will be initiated in the evening of Day 1, after all baseline assessments have been completed and the patient has been randomized.

Oral administration is as follows:

Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo

Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14):
5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21):

7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo • Week 4 to end of treatment period (p.m. dose of Day 21 to

a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo

If the next higher dose after each study drug increase is not tolerated, the dose will be reduced to the previous tolerated dose.

Every week (before the next dose increase) the patient will be re-evaluated. This includes ECG monitoring at approximately 5 hours post-morning dose (time of Tmax) to surveil for deleterious effects on ECG intervals (particularly the QTc interval) and rhythm. Drug titration will be dependent on investigator or designate interrogation of the ECGs and the absence of new, clinically significant abnormalities on those ECGs.

Vital signs, concurrent medication and Adverse Events (AEs), including Serious Adverse Events (SAEs) will be recorded, blood chemistry including liver function tests, hematology as well as INR assessments will be carried out.

Final efficacy assessments (including a second CMR) will take place after 12 weeks of study treatment. A final safety assessment will take place after 13 weeks, 1 week after completion of study treatment.

Conditions studied

Acute Myocarditis

Keywords

Pharmaceutically produced CBC
THC < 5ppm

In context

Lead sponsor

Cardiol Therapeutics Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Males and females 18 years of age or older
Diagnosed with acute myocarditis including:
1. Clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness), preferably followed by elevated troponin PLUS
2. CMR diagnosis (Lake Louise Criteria) within 10 days prior to randomization OR
3. Endomyocardial biopsy (EMB) showing either cellular inflammation and/or immunohistochemistry consistent with inflammation.
Male subjects with partners of childbearing potential who have had a vasectomy or are willing to use double barrier contraception methods during the conduct of the study and for 2 months after the last dose of study drug.
Women of childbearing potential willing to use an acceptable method of contraception starting with study drug administration and for a minimum of 2 months after study completion. Otherwise, women must be post- menopausal.

Exclusion criteria

Exclusion Criteria:

Coronary artery disease (CAD) defined as a stenosis greater than 50% in a major epicardial coronary artery
Severe valvular heart disease
Inability to safely undergo CMR including administration of gadolinium
Estimated glomerular filtration rate (eGFR) \< 30 ml/min
Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal (ULN) or ALT or AST >3x ULN plus bilirubin >2x ULN.
Sepsis, defined as documented bacteremia at the time of presentation or other documented active infection.
Severe left ventricular (LV) dysfunction requiring inotropic support, left ventricular assist device (LVAD) or other circulatory assist devices, or urgent need for transplantation
Documented biopsy evidence of giant cell or eosinophilic myocarditis
Prior history of sustained ventricular arrhythmia
Acute coronary syndrome within 30 days
Percutaneous coronary intervention within 30 days
History of QT interval prolongation or QTc interval > 500 msec
Treated with strong inducers CYP3A4 or CYP2C19, as listed in Appendix 17.8
Treated with digoxin and/or type 1 or 3 antiarrhythmics
Current participation in any research study involving investigational drugs or devices
Inability or unwillingness to give informed consent
Ongoing drug or alcohol abuse
Women who are pregnant or breastfeeding
Current diagnosis of cancer, with the exception of non-melanoma skin cancer
Any factor, which would make it unlikely that the patient can comply with the study procedures
On any cannabinoid during the past month
Body weight > 170 kg
Showing suicidal tendency as per the C-SSRS, administered at screening

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 109 participants (actual)

Study arms

Experimental
CardiolRx
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
Drug: CardiolRx
Placebo comparator
Placebo
* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
Drug: CardiolRx

Interventions

DrugCardiolRx
Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
Also known as: Cannabidiol

What researchers measure

Primary outcomes

Extracellular Volume (ECV)
Change of ECV from baseline at 12 weeks, measured by cardiac Cardiac MRI. ECV is measuring the degree of edema and fibrosis. The unit of measure was percentage. It was the percentage of myocardial tissue that is extracellular space (i.e. fraction of the myocardium occupied by extracellular matrix and interstitial fluid).
Time frame: 12 weeks post randomization
Global Longitudinal Strain (GLS)
The outcome was the change in GLS from baseline at 12 weeks, measured by cardiac Cardiac MRI. GLS is a predictor of cardiac function. The unit of measure is percentage. It is the percent change in myocardial length relative to its original (end-diastolic) length along the long axis. Longitudinal strain during systole is usually negative, because the ventricle shortens; normal peak GLS in healthy adults is around -20% (i.e., 20% shortening relative to original length)
Time frame: 12 weeks post randomization

Secondary outcomes

Change in Left-ventricular Ejection Fraction (LVEF) From Baseline at 12 Weeks
Left-ventricular ejection fraction (LVEF) as measured by Cardiac MRI at 12 weeks. LVEF is a measure of cardiac function. The unit of measure is percentage. It is the percent of end-diastolic blood volume in the left ventricle that is ejected with each systolic contraction. Mathematically, LVEF = (stroke volume/end-diastolic volume) x 100.
Time frame: 12 weeks post randomization

Other outcomes

Change in Left-ventricular Mass From Baseline at 12 Weeks
Left-ventricular mass at week 12, measured with cardiac MRI. Unit of measure is grams (g) of myocardium. The mass of left-ventricular myocardial tissue was calculated from lCMR using geometric assumptions (e.g., Devereux/ASE cube formula) and myocardial density.
Time frame: From baseline to 12 weeks of treatment

Results

Posted Jun 17, 2026

Limitations and caveats

The reduced number of analyzable CMRs with respect to ECV was the main limitation in this trial.

Participant flow

166 patients signed informed consent between July 28, 2022, and October 31,2024, in 29 centers in Brazil; France; Israel and the United States. There were 57 screening failures and 109 patients were randomized to either CardiolRx™ (N=56) or Placebo (N=53). All randomized patients started the IMP and completed the study as planned - no patient withdrew prematurely from follow-up. In total, 11 patients discontinued the IMP before the Week 12 visit, 6 on CardiolRx and 5 on placebo.

Participant flow — Overall Study
Milestone	CardiolRx	Placebo
Started	56	53
Completed	56	53
Not completed	0	0

Outcome measures

PrimaryExtracellular Volume (ECV)

Change of ECV from baseline at 12 weeks, measured by cardiac Cardiac MRI. ECV is measuring the degree of edema and fibrosis. The unit of measure was percentage. It was the percentage of myocardial tissue that is extracellular space (i.e. fraction of the myocardium occupied by extracellular matrix and interstitial fluid).

Time frame:: 12 weeks post randomization
Reported as:: Mean · percentage of tissue volume outside cell

Extracellular Volume (ECV)
percentage of tissue volume outside cell	CardiolRx	Placebo
Extracellular Volume (ECV)	-1.88 ± 3.25	-1.60 ± 4.57

Statistical analysis

CardiolRx vs Placebo · ANCOVA · p = 0.2609 (Non-adjusted for multiple comparisons) · Mean difference (final values): -0.87 · 95% CI -2.40 to 0.66adjusted for baseline values

PrimaryGlobal Longitudinal Strain (GLS)

The outcome was the change in GLS from baseline at 12 weeks, measured by cardiac Cardiac MRI. GLS is a predictor of cardiac function. The unit of measure is percentage. It is the percent change in myocardial length relative to its original (end-diastolic) length along the long axis. Longitudinal strain during systole is usually negative, because the ventricle shortens; normal peak GLS in healthy adults is around -20% (i.e., 20% shortening relative to original length)

Time frame:: 12 weeks post randomization
Reported as:: Mean · % of change in ventricle length

Global Longitudinal Strain (GLS)
% of change in ventricle length	CardiolRx	Placebo
Global Longitudinal Strain (GLS)	-0.68 ± 3.6	-0.62 ± 3.68

Statistical analysis

CardiolRx vs Placebo · ANCOVA · p = 0.9021 (non-adjusted for multiple comparisons) · Mean difference (final values): -0.07 · 95% CI -1.21 to 1.07

SecondaryChange in Left-ventricular Ejection Fraction (LVEF) From Baseline at 12 Weeks

Left-ventricular ejection fraction (LVEF) as measured by Cardiac MRI at 12 weeks. LVEF is a measure of cardiac function. The unit of measure is percentage. It is the percent of end-diastolic blood volume in the left ventricle that is ejected with each systolic contraction. Mathematically, LVEF = (stroke volume/end-diastolic volume) x 100.

Time frame:: 12 weeks post randomization
Reported as:: Mean · percentage

Change in Left-ventricular Ejection Fraction (LVEF) From Baseline at 12 Weeks
percentage	CardiolRx	Placebo
Change in Left-ventricular Ejection Fraction (LVEF) From Baseline at 12 Weeks	0.65 ± 8.38	1.75 ± 9.05

Statistical analysis

CardiolRx vs Placebo · ANCOVA · p = 0.6520 (non-adjusted for multiple comparisons) · Mean difference (final values): 0.55 · 95% CI -1.85 to 2.94

Other pre-specifiedChange in Left-ventricular Mass From Baseline at 12 Weeks

Left-ventricular mass at week 12, measured with cardiac MRI. Unit of measure is grams (g) of myocardium. The mass of left-ventricular myocardial tissue was calculated from lCMR using geometric assumptions (e.g., Devereux/ASE cube formula) and myocardial density.

Time frame:: From baseline to 12 weeks of treatment
Reported as:: Mean · gram

Change in Left-ventricular Mass From Baseline at 12 Weeks
gram	CardiolRx	Placebo
Change in Left-ventricular Mass From Baseline at 12 Weeks	-11.11 ± 15.32	-2.83 ± 23.39

Statistical analysis

CardiolRx vs Placebo · ANCOVA · p = 0.0117 · Mean difference (final values): -9.23 · 95% CI -16.36 to -2.11

Post-hocChange in Extracellular Volume (ECV) in ml From Baseline at 12 Weeks

The total Extracellular Volume (ECV) was calculated in mL using the following formula:Total ECV volume (mL) = ܸECV fraction (%) x LV mass (g)/ 1.05 where 1.05 = the specificgravity of myocardium in g/mL. It is the absolute extracellular volume of the tissue or body compartment, reported as physical volume instead of fraction or percent.

Time frame:: baseline to 12 weeks
Reported as:: Mean · mL

Change in Extracellular Volume (ECV) in ml From Baseline at 12 Weeks
mL	CardiolRx	Placebo
Change in Extracellular Volume (ECV) in ml From Baseline at 12 Weeks	-5.96 ± 7.35	-2.73 ± 9.48

Statistical analysis

CardiolRx vs Placebo · ANCOVA · p = 0.0538 (non-adjusted for multiple comparisons) · Mean difference (final values): -3.67 · 95% CI -7.41 to 0.06

Adverse events

Collected over 16 weeks in France and 13 weeks for rest of the world (Brazil, Israel and US). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cannabidiol, Pharmaceutically Produced With < 5 Ppm THC	0/56 (0%)	6/56 (10.7%)	42/56 (75%)
Placebo	0/53 (0%)	3/53 (5.7%)	35/53 (66%)

Most frequent serious events

Most frequent serious events
Event	Cannabidiol, Pharmaceutically Produced With < 5 Ppm THC	Placebo
PalpitationCardiac disorders	0/56	1/53
Alanine aminotransferase increasedInvestigations	1/56	1/53
Aspartate aminotransferase increasedInvestigations	0/56	1/53
HypocalcemiaMetabolism and nutrition disorders	0/56	1/53
MyocarditisCardiac disorders	1/56	0/53
Ventricular TachycardiaCardiac disorders	1/56	0/53
GastritisGastrointestinal disorders	1/56	0/53
Chest painGeneral disorders	1/56	0/53
Transaminases increasedInvestigations	1/56	0/53
TremorNervous system disorders	1/56	0/53

Most frequent other events

Most frequent other events
Event	Cannabidiol, Pharmaceutically Produced With < 5 Ppm THC	Placebo
DiarrheaGastrointestinal disorders	18/56	11/53
Chest painGeneral disorders	9/56	4/53
AstheniaGeneral disorders	1/56	7/53
NauseaGastrointestinal disorders	5/56	2/53
Alanine aminotransferase increasedInvestigations	5/56	3/53
PalpitationsCardiac disorders	1/56	4/53
NasopharyngitisInfections and infestations	0/56	3/53
RashSkin and subcutaneous tissue disorders	3/56	1/53

Baseline characteristics

modified ITT analysis population

Age, Continuous
Age, Continuous(years)	CardiolRx	Placebo	Total
Mean	35.8 ± 15.35	39.6 ± 15.47	37.7 ± 15.45

Sex: Female, Male
Sex: Female, Male(Participants)	CardiolRx	Placebo	Total
Female	10	9	19
Male	39	41	80

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	CardiolRx	Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	0	1	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	5	2	7
White	38	41	79
More than one race	0	1	1
Unknown or Not Reported	6	5	11

Region of Enrollment
Region of Enrollment(participants)	CardiolRx	Placebo	Total
United States	4	4	8
Brazil	22	28	50
Israel	7	7	14
France	16	11	27

Global longitudinal strain (GLS)
Global longitudinal strain (GLS)(%)	CardiolRx	Placebo	Total
Mean	-15.35 ± 3.10	-15.34 ± 4.06	-15.35 ± 3.60

Extracellular volume (ECV)
Extracellular volume (ECV)(%)	CardiolRx	Placebo	Total
Mean	29.74 ± 4.47	30.83 ± 4.31	30.29 ± 4.40

Left-ventricular ejection fraction (LVEF)
Left-ventricular ejection fraction (LVEF)(%)	CardiolRx	Placebo	Total
Mean	61.90 ± 8.88	59.35 ± 10.79	60.61 ± 9.93

Study locations

37 sites

MedStar Heart and Vascular Institute
Washington D.C., District of Columbia 20010, United States
Massachusetts General Hospital site
Boston, Massachusetts 02114, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407, United States
Cleveland Clinic
Cleveland, Ohio 44195, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213, United States
Virginia Commonwealth University
Richmond, Virginia 23298, United States
Nupec-Orizonti
Belo Horizonte, Minas Gerais 30210090, Brazil
PUC trials
Curitiba, Paraná 80230-130, Brazil
Complexo Hospitalar de Niterói
Niterói, Rio de Janeiro 24020-096, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul 90035-001, Brazil
Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul 90035-003, Brazil
Hospital Nove de Julho
São Paulo, São Paulo 01409-002, Brazil
Hospital Felicio Rocho - Fundação Felice Rosso
Belo Horizonte, Brazil
Hospital Angelina Caron
Campina Grande do Sul, Brazil
Hospital São Lucas
Porto Alegre, Brazil
Instituto D´Or de Pesquisa e Ensino
Rio de Janeiro, 22281-100, Brazil
Hospital Pró-Cardíaco
Rio de Janeiro, Brazil
Hospital Regional de São José
São José, Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, 01223-001, Brazil
Instituto do Coração - InCor
São Paulo, Brazil
University of Alberta Hospital
Edmonton, Alberta T6G2B7, Canada
McGill University Health Centre
Montreal, Quebec H4A 3J1, Canada
Hopital Louis Pradel Hospices Civils de Lyon
Bron, 69500, France
CHU de Montpellier
Montpellier, 34295, France
Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029, France
Hôpital Lariboisière - Département de Cardiologie
Paris, 75475, France
Hopital Bichat Claude Bernard
Paris, France
Hôpital européen Georges-Pompidou
Paris, France
Institut de Cardiologie hopital Pitié Salpêtrière
Paris, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, France
Hôpital Foch
Suresnes, 92150, France
Chu Rangueil
Toulouse, France
Barzilai Medical Center
Ashkelon, 7830604, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Beilinson Hospital, Rabin medical Center
Petah Tikva, 4941492, Israel
Tel Aviv Sourasky Medical Center (Ichilov)
Tel Aviv, 6423906, Israel
Shamir Medical Center (Assaf Harofeh)
Zrifin, 70300, Israel

References and documents

Publications

Lee WS, Erdelyi K, Matyas C, Mukhopadhyay P, Varga ZV, Liaudet L, Hasku G, Cihakova D, Mechoulam R, Pacher P. Cannabidiol Limits T Cell-Mediated Chronic Autoimmune Myocarditis: Implications to Autoimmune Disorders and Organ Transplantation. Mol Med. 2016 Sep;22:136-146. doi: 10.2119/molmed.2016.00007. Epub 2016 Jan 8. PubMed 26772776 ↗
McNamara DM, Cooper LT, Friedrich MG, Arbel Y, Bhimaraj A, Bocchi E, Hamer A, Herdy AH, Kerneis M, Liu PP, Parker AB, Pocock SJ, Smith ER, Tang WHW, Torre-Amione G, Tschope C; ARCHER Study Group. Impact of cannabidiol on myocardial recovery in patients with acute myocarditis: primary results of the ARCHER study. ESC Heart Fail. 2026 Feb 3;13(1):xvaf034. doi: 10.1093/eschf/xvaf034. PubMed 41711722 ↗

Study documents

Study protocol · Dec 19, 2024
Statistical analysis plan · May 9, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

1 registry update since Sep 25, 2026

Minor edits

Nothing that changes what the study is or who can join. Edited: verification date, site details and references

1 update, last Sep 30, 2026

Show all 1 update

Sep 30, 2026
Minor edits only
+ 3 other changes: verification date, site details and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05180240
Lead sponsor: Cardiol Therapeutics Inc.
Responsible party: Sponsor
First posted: Jan 6, 2022
Start date: Jul 28, 2022
Primary completion: Jan 31, 2025
Completion: Feb 4, 2025
Results posted: Jun 17, 2026
Last update: Sep 30, 2026

Study contacts

Dennis McNamara, MD

study chair · University of Pittsburgh

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Other studies from this sponsor

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Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

Study summary

Conditions studied

Keywords

In context

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Other outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies from this sponsor

Inclusion criteria

Exclusion criteria