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Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PXL065

Placebo oral tablet

About this trial

This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients have given written informed consent
Body mass index (BMI) ≤ 50 kg/m²
For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or under stable oral glucose lowering drug
Estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73m²
Liver fat content ≥ 8% on MRI-PDFF
Qualifying liver biopsy (NAS) ≥ 4 and fibrosis score F1, F2 or F3
Effective contraception for women of child bearing potential

Exclusion Criteria:

Evidence of another form of liver disease
Evidence of liver cirrhosis
Evidence of hepatic impairment
Positive serologic evidence of current infectious liver disease
History of excessive alcohol intake
Acute cardiovascular disease within 6 months prior to Randomization
Any disease which in the Investigator's opinion which in the Investigator's opinion would exclude the patient from the study
Use of non-permitted concomitant medication
Pregnancy or lactation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

PXL065 Dose 1

PXL065 Dose 2

PXL065 Dose 3

Placebo oral tablet

Outcomes

Primary Outcome Measures

Relative Change From Baseline to Week 36 in the Percentage of Liver Fat Content (LFC) (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF])

MRI-PDFF was performed using a standardized imaging protocol, and a central reader analyzed the results. The central reader for this study trained the local imaging centers and provided the imaging manual. Relative change from baseline to Week 36 was calculated as follows: (LFC at Week 36 - LFC at baseline) / LFC at baseline x 100. The primary analysis was performed for the Intent-to-treat Set (ITTS) using an analysis of covariance (ANCOVA) model adjusting for treatment, for stratification factors, and for the baseline LFC as a continuous covariate. LFC missing values at Week 36 were imputed using a multivariate imputation approach by fully conditional specification regression method assuming Missing At Random Mechanism.

Relative Change From Baseline to Week 36 in the Percentage of LFC (Assessed by MRI-PDFF) (Wilcoxon Test Sensitivity Analysis)

MRI-PDFF was performed using a standardized imaging protocol, and a central reader analyzed the results. The central reader for this study trained the local imaging centers and provided the imaging manual. The sensitivity analysis was performed for the Intent-to-treat Set (ITTS) using a non parametric pairwise Wilcoxon test stratified according to T2DM status and NASH CRN fibrosis scoring system. LFC missing values at Week 36 were imputed using a multivariate imputation approach by fully conditional specification regression method assuming Missing At Random Mechanism.

Secondary Outcome Measures

Absolute Change From Baseline to Week 36 in the Percentage of LFC (Assessed by MRI-PDFF)

MRI-PDFF was performed using a standardized imaging protocol, and a central reader analyzed the results. The central reader for this study trained the local imaging centers and provided the imaging manual. Absolute change from baseline to Week 36 was calculated as follows: LFC at Week 36 - LFC at baseline. The analysis of the absolute change in LFC was performed for the Intent-to-treat Set (ITTS) using an ANCOVA model adjusting for treatment, for stratification factors, and for the baseline LFC as a continuous covariate. LFC missing values at Week 36 were imputed using a multivariate imputation approach by fully conditional specification regression method assuming Missing At Random Mechanism.

Percentage of Responders (Relative Reduction of at Least 30% in LFC) at Week 36

Responders were defined as patients who achieved a clinically meaningful relative reduction of at least 30% in LFC from baseline to Week 36 as assessed by MRI-PDFF

Change From Baseline to Week 36 in Alanine Amino Transferase (ALT)

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Percentage of Responders (Normalization of ALT)

Normalization of ALT was analyzed in the subset of patients with baseline greater than the upper reference range. Patients were classed as responders if ALT normalized, i.e. decreased to < upper reference range at a post baseline visit.

Change From Baseline to Week 36 in Aspartate Amino Transferase (AST)

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Percentage of Responders (Normalization of AST)

Normalization of AST was analyzed in the subset of patients with baseline greater than the upper reference range. Patients were classed as responders if AST normalized, i.e. decreased to < upper reference range at a post baseline visit.

Change From Baseline to Week 36 in Gamma Glutamyltransferase (GGT)

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Change From Baseline to Week 36 in Alkaline Phosphatase (ALP)

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Change From Baseline to Week 36 in Pro-C3

Pro-C3 is the released N-terminal pro-peptide of type III collagen. It is a fibrosis marker. Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Change From Baseline to Week 36 in Enhanced Liver Fibrosis (ELF) Score

ELF score is an extracellular matrix marker set consisting of tissue inhibitor of metalloproteinases 1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP) and hyaluronic acid (HA) showing good correlations with fibrosis stages in chronic liver disease.The set cutoffs for this scoring are: ELF < 7.7: no to mild fibrosis; ELF between 7.7 - 9.8: moderate fibrosis; ELF between 9.8 - 11.3: severe fibrosis; and ELF > or = 11.3: cirrhosis. Blood samples used for TIMP-1, PIIINP and HA were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Change From Baseline to Week 36 in Fibrosis-4 (Fib-4) Score

Fib-4 score is a non invasive method based on clinical determinations that indicates the level of fibrosis/ scarring of the liver. The set cutoffs for this scoring are: Fib-4 < 1.45: absence of cirrhosis; Fib-4 between 1.45 - 3.25: inconclusive and Fib-4 > 3.25: cirrhosis. Fib-4 score was calculated as (Age [years] × AST [U/L]) / (platelet [10^9/L] × √[ALT [U/L]]). Blood samples used for AST, ALT and platelet counts were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Change From Baseline to Week 36 in NAFLD Fibrosis Score

The NFS is based on a combination of clinical and laboratory measurements (i.e. age, glycemia, BMI, platelet, albumin and AST/ALT ratio). The set cutoffs for this scoring are: < -1.455 for exclusion of advance fibrosis, > -1.455 to < or = 0.675 for indetermined, and > 0.675 for presence of advance fibrosis. NFS was calculated as: 1.675 + 0.037 x age (years) + 0.094 x BMI (kg/m²) + 1.13 x Impaired Fasting Glucose or Diabetes (yes =1; no=0) + 0.99 x AST/ALT ratio - 0.013 x platelet (10^9/L) - 0.66 x albumin (g/dL)

Improvement of at Least 1 Point in NASH CRN Fibrosis Score From Baseline to Week 36

Improvement in fibrosis is defined as a decrease of at least one stage in NASH CRN fibrosis score.

Improvement in NAS of at Least 2 Points With no Worsening in NASH CRN Fibrosis Score From Baseline to Week 36

NAS is the NAFLD activity score, calculated as the sum of steatosis, lobular inflammation and ballooning scores. Improvement in NAS is defined as a decrease of at least 2 points. No worsening in NASH CRN fibrosis score means that the score remained stable or decreased.

NASH Resolution With no Worsening in NASH CRN Fibrosis Score at Week 36

NASH resolution is defined as a NAS score of 0-1 for inflammation, 0 for ballooning, and any value for steatosis. No worsening in NASH CRN fibrosis score means that the score remained stable or decreased.

NASH Resolution With Improvement of at Least 1 Point in NASH CRN Fibrosis Score at Week 36

NASH resolution is defined as a NAS score of 0-1 for inflammation, 0 for ballooning, and any value for steatosis. Improvement in fibrosis is defined as a decrease of at least one stage in NASH CRN fibrosis score.

Change From Baseline to Week 36 in Glycated Hemoglobin (HbA1c)

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Change From Baseline to Week 36 in Fasting Plasma Glucose (FPG)

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Change From Baseline to Week 36 in Serum Insulin

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Change From Baseline to Week 36 in Serum C-peptide

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Change From Baseline to Week 36 in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

HOMA-IR was calculated as: Serum C-peptide (ng/mL) × FPG (mg/dL) / 405 Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory. HOMA-IR is an indicator of insulin resistance. The higher the value, the greater the insulin resistance. There is no minimum or maximum index score.

Change From Baseline to Week 36 in Quantitative Insulin Sensitivity Check Index (QUICKI)

The QUICKI was calculated as: 1 / (log (FPG [mg/dL]) + log (C-peptide [ng/mL])). Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory. QUICKI is an indicator of insulin resistance. Lower numbers reflect greater insulin resistance. There is no minimum or maximum index score.

Change From Baseline to Week 36 in Adipo-IR

The Adipo-IR was calculated as: Fasting serum Free Fatty Acids (mmol/L) x Fasting serum insulin (μIU/mL) Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory. The Adipo-IR is a marker of adipose tissue insulin resistance. Higher the value, the greater the insulin resistance. There is no minimum or maximum index score.

Change From Baseline to Week 36 in Adiponectin

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Change From Baseline to Week 36 in Weight

Body weight was measured using a scale with appropriate resolution, placed on a stable, flat surface. Shoes, bulky layers of clothing, and jackets had to be removed so that only light clothing remained.

Full Information

NCT ID

NCT04321343

First Posted

March 23, 2020

Last Updated

August 4, 2023

Sponsor

Poxel SA

1. Study Identification

Unique Protocol Identification Number

NCT04321343

Brief Title

Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)

Official Title

A 36-week, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Efficacy and Safety of PXL065 Versus Placebo in Noncirrhotic Biopsy-proven NonAlcoholic SteatoHepatitis (NASH) Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

June 8, 2022 (Actual)

Study Completion Date

June 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poxel SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will assess the effect of 3 doses of PXL065 versus placebo on liver fat content in NASH patients after 36 weeks of treatment

Detailed Description

The study will be performed in patients with NASH. The primary endpoint will be the assessment of the change in the percentage of liver fat content (assessed by MRI-PDFF).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NASH - Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

PXL065 Dose 1

Arm Title

Group 2

Arm Type

Experimental

Arm Description

PXL065 Dose 2

Arm Title

Group 3

Arm Type

Experimental

Arm Description

PXL065 Dose 3

Arm Title

Group 4

Arm Type

Placebo Comparator

Arm Description

Placebo oral tablet

Intervention Type

Drug

Intervention Name(s)

PXL065

Intervention Description

PXL065 oral tablet

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Intervention Description

Placebo oral tablet

Primary Outcome Measure Information:

Title

Relative Change From Baseline to Week 36 in the Percentage of Liver Fat Content (LFC) (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF])

Description

Time Frame

Baseline and Week 36

Title

Relative Change From Baseline to Week 36 in the Percentage of LFC (Assessed by MRI-PDFF) (Wilcoxon Test Sensitivity Analysis)

Description

MRI-PDFF was performed using a standardized imaging protocol, and a central reader analyzed the results. The central reader for this study trained the local imaging centers and provided the imaging manual. The sensitivity analysis was performed for the Intent-to-treat Set (ITTS) using a non parametric pairwise Wilcoxon test stratified according to T2DM status and NASH CRN fibrosis scoring system. LFC missing values at Week 36 were imputed using a multivariate imputation approach by fully conditional specification regression method assuming Missing At Random Mechanism.

Time Frame

Baseline and Week 36

Secondary Outcome Measure Information:

Title

Absolute Change From Baseline to Week 36 in the Percentage of LFC (Assessed by MRI-PDFF)

Description

MRI-PDFF was performed using a standardized imaging protocol, and a central reader analyzed the results. The central reader for this study trained the local imaging centers and provided the imaging manual. Absolute change from baseline to Week 36 was calculated as follows: LFC at Week 36 - LFC at baseline. The analysis of the absolute change in LFC was performed for the Intent-to-treat Set (ITTS) using an ANCOVA model adjusting for treatment, for stratification factors, and for the baseline LFC as a continuous covariate. LFC missing values at Week 36 were imputed using a multivariate imputation approach by fully conditional specification regression method assuming Missing At Random Mechanism.

Time Frame

Baseline and Week 36

Title

Percentage of Responders (Relative Reduction of at Least 30% in LFC) at Week 36

Description

Responders were defined as patients who achieved a clinically meaningful relative reduction of at least 30% in LFC from baseline to Week 36 as assessed by MRI-PDFF

Time Frame

Baseline and Week 36

Title

Change From Baseline to Week 36 in Alanine Amino Transferase (ALT)

Description

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Time Frame

Baseline to Week 36

Title

Percentage of Responders (Normalization of ALT)

Description

Time Frame

Baseline to Week 36

Title

Change From Baseline to Week 36 in Aspartate Amino Transferase (AST)

Description

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Time Frame

Baseline to Week 36

Title

Percentage of Responders (Normalization of AST)

Description

Time Frame

Baseline to Week 36

Title

Change From Baseline to Week 36 in Gamma Glutamyltransferase (GGT)

Description

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Time Frame

Baseline to Week 36

Title

Change From Baseline to Week 36 in Alkaline Phosphatase (ALP)

Description

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Time Frame

Baseline to Week 36

Title

Change From Baseline to Week 36 in Pro-C3

Description

Time Frame

Baseline and Week 36

Title

Change From Baseline to Week 36 in Enhanced Liver Fibrosis (ELF) Score

Description

Time Frame

Baseline and Week 36

Title

Change From Baseline to Week 36 in Fibrosis-4 (Fib-4) Score

Description

Time Frame

Baseline and Week 36

Title

Change From Baseline to Week 36 in NAFLD Fibrosis Score

Description

Time Frame

Baseline and Week 36

Title

Improvement of at Least 1 Point in NASH CRN Fibrosis Score From Baseline to Week 36

Description

Improvement in fibrosis is defined as a decrease of at least one stage in NASH CRN fibrosis score.

Time Frame

Baseline and Week 36

Title

Improvement in NAS of at Least 2 Points With no Worsening in NASH CRN Fibrosis Score From Baseline to Week 36

Description

Time Frame

Baseline and Week 36

Title

NASH Resolution With no Worsening in NASH CRN Fibrosis Score at Week 36

Description

Time Frame

Baseline and Week 36

Title

NASH Resolution With Improvement of at Least 1 Point in NASH CRN Fibrosis Score at Week 36

Description

Time Frame

Baseline and Week 36

Title

Change From Baseline to Week 36 in Glycated Hemoglobin (HbA1c)

Description

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Time Frame

Baseline to Week 36

Title

Change From Baseline to Week 36 in Fasting Plasma Glucose (FPG)

Description

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Time Frame

Baseline to Week 36

Title

Change From Baseline to Week 36 in Serum Insulin

Description

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Time Frame

Baseline to Week 36

Title

Change From Baseline to Week 36 in Serum C-peptide

Description

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Time Frame

Baseline to Week 36

Title

Change From Baseline to Week 36 in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

Description

Time Frame

Baseline to Week 36

Title

Change From Baseline to Week 36 in Quantitative Insulin Sensitivity Check Index (QUICKI)

Description

Time Frame

Baseline to Week 36

Title

Change From Baseline to Week 36 in Adipo-IR

Description

Time Frame

Baseline to Week 36

Title

Change From Baseline to Week 36 in Adiponectin

Description

Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

Time Frame

Baseline to Week 36

Title

Change From Baseline to Week 36 in Weight

Description

Time Frame

Baseline to Week 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients have given written informed consent Body mass index (BMI) ≤ 50 kg/m² For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or under stable oral glucose lowering drug Estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73m² Liver fat content ≥ 8% on MRI-PDFF Qualifying liver biopsy (NAS) ≥ 4 and fibrosis score F1, F2 or F3 Effective contraception for women of child bearing potential Exclusion Criteria: Evidence of another form of liver disease Evidence of liver cirrhosis Evidence of hepatic impairment Positive serologic evidence of current infectious liver disease History of excessive alcohol intake Acute cardiovascular disease within 6 months prior to Randomization Any disease which in the Investigator's opinion which in the Investigator's opinion would exclude the patient from the study Use of non-permitted concomitant medication Pregnancy or lactation

Facility Information:

Facility Name

Study site 11

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Study site 12

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

Study site 13

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Study site 21

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Study site 17

City

Chula Vista

State/Province

California

ZIP/Postal Code

91910

Country

United States

Facility Name

Study site 16

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Study site 04

City

Huntington Park

State/Province

California

ZIP/Postal Code

90255

Country

United States

Facility Name

Study site 05

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Study site 22

City

Orange

State/Province

California

ZIP/Postal Code

92866

Country

United States

Facility Name

Study site 06

City

Panorama City

State/Province

California

ZIP/Postal Code

90402

Country

United States

Facility Name

Study site 07

City

Santa Ana

State/Province

California

ZIP/Postal Code

92704

Country

United States

Facility Name

Study site 15

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33434

Country

United States

Facility Name

Study site 31

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

Study site 08

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Study site 01

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34240

Country

United States

Facility Name

Study site 28

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50265

Country

United States

Facility Name

Study site 18

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

61431

Country

United States

Facility Name

Study site 24

City

Flowood

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

Study site 10

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Study site 27

City

East Syracuse

State/Province

New York

ZIP/Postal Code

13057

Country

United States

Facility Name

Study site 14

City

Fayetteville

State/Province

North Carolina

ZIP/Postal Code

28304

Country

United States

Facility Name

Study site 29

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29485

Country

United States

Facility Name

Study site 25

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37411

Country

United States

Facility Name

Study site 30

City

Clarksville

State/Province

Tennessee

ZIP/Postal Code

37040

Country

United States

Facility Name

Study Site 02

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Study site 19

City

Austin

State/Province

Texas

ZIP/Postal Code

78746

Country

United States

Facility Name

Study site 09

City

Edinburg

State/Province

Texas

ZIP/Postal Code

78539

Country

United States

Facility Name

Study site 23

City

Edinburg

State/Province

Texas

ZIP/Postal Code

78539

Country

United States

Facility Name

Pinnacle Clinical Research (Study site 20)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)

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Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)

NASH - Nonalcoholic Steatohepatitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial