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Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (GLOW6)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

NVA237 50 µg and indacaterol 150 µg

Placebo to NVA237 and indacaterol 150 µg

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Indacaterol, Glycopyrronium Bromide, COPD, bronchodilation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 0.70 at screening.
Current or ex-smokers who have a smoking history of at least 10 pack years
Symptomatic patients according to daily diary data.

Exclusion Criteria:

Pregnant or nursing (lactating) women.
Women of child-bearing potential unless using adequate contraception.
Patients with Type I or uncontrolled Type II diabetes.
Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged
Patients with paroxysmal (e.g. intermittent) atrial fibrillation
Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)

Other protocol-defined inclusion/exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NVA237 + indacaterol

Placebo to NVA237 + indacaterol

Arm Description

Outcomes

Primary Outcome Measures

Trough Forced Expiratory Volume at 1 Second (FEV1)

Centralized spirometry according to internationally accepted standards was used. The model contained treatment, baseline smoking status and baseline inhaled corticosteroid (ICS) use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in region as a random effect. If trough FEV1 was missing at week 12, the latest non-missing pre-dose trough FEV1 (the mean of 45 and 15 min pre-dose measurements) from day 29, 57 or 84) was carried forward. These measurements had to have been taken before the next dose of study medication. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.

Secondary Outcome Measures

FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose

Centralized spirometry was used according to internationally accepted standards was used. The trapezoidal rule was applied to calculate FEV1 Area Under the Curve (AUC) and then normalized to the length of time. Whether the participants had complete or incomplete FEV1 assessments in respective time ranges, their AUCs were calculated based on the existing FEV1 measurements (i.e., the missing FEV1 measurements were not interpolated). Specifically, for those participants who had a FEV1 assessment at only one time-point, their AUC was approximated by the observed FEV1. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.

Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks

Centralized spirometry was used according to internationally accepted standards was used. Peak FEV1 was defined as the maximum FEV1 during the first 4 hours post morning dosing. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in a region as a random effect. If all FEV1 measurements were missing from 30 minutes onward, the peak FEV1 was not calculated. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.

FEV1 at Individual Time-points

Centralized spirometry according to internationally accepted standards was used. FEV1 was measured at all post-dose time points up to 4 hours, and at 23 hours 15 minutes and 23 hours 45 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.

Forced Vital Capacity (FVC) at Individual Time-points

FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 minutes and 23 hours 45 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FVC, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect. FVC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.

Inspiratory Capacity (IC) at Individual Time-points

Inspiratory Capacity (IC) was measured at 20 min pre-dose and at post-dose at 25 minutes, 1 hour 55 minutes, 3 hours 55 minutes and 23 hours 40 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of IC, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect. IC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.

Change From Baseline in Mean Daily Number of Puffs of Rescue Medication

The number of puffs of rescue medication taken in the previous 12 hours was recorded in the patient diary in the morning and evening. The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening), then a half day was used in the denominator.

Transitional Dyspnea Index (TDI) Focal Score

Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during treatment using the Transitional Dyspnea Index (TDI). Analysis was done via mixed model. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of 1 is considered a minimal clinically important difference.

Change From Baseline in Mean Daily Total and Individual Symptom Scores

The symptoms (respiratory, cough, wheeze, sputum color, sputum production, breathlessness, sore throat, nasal discharge or congestion, and fever) for the whole active treatment period was analyzed using a mixed model, which contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline symptom score, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect. Each symptom was scored as 0, 1, 2 or 3 where the description for each score varied. For each of the symptoms, the range of scores from 0 to 3 represented an increase in symptoms where 0 represented little to no symptom and 3 represented severe or worst symptom. The total symptom score, which is the sum of the individual scores, ranged from 0 (best possible outcome) to 27 (worst possible outcome).

Number of Participants With Adverse Events and Serious Adverse Events

All study emergent adverse events including Chronic Obstructive Pulmonary Disease exacerbations were monitored from screening through the end of study.

Full Information

NCT ID

NCT01604278

First Posted

May 21, 2012

Last Updated

November 12, 2014

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01604278

Brief Title

Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Acronym

GLOW6

Official Title

A 12-week Multi-center, Randomized, Double-blind, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of the Co-administration of NVA237 + Indacaterol Once Daily vs. Indacaterol Once Daily in Patients With Moderate to Severe COPD

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

This study assessed the efficacy, safety and tolerability of the co-administration of NVA237 plus indacaterol taken once daily versus indacaterol taken once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease.

6. Conditions and Keywords

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

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Indacaterol, Glycopyrronium Bromide, COPD, bronchodilation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

449 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NVA237 + indacaterol

Arm Type

Active Comparator

Arm Title

Placebo to NVA237 + indacaterol

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

NVA237 50 µg and indacaterol 150 µg

Other Intervention Name(s)

Glycopyrronium Bromide

Intervention Description

NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.

Intervention Type

Drug

Intervention Name(s)

Placebo to NVA237 and indacaterol 150 µg

Intervention Description

Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.

Primary Outcome Measure Information:

Title

Trough Forced Expiratory Volume at 1 Second (FEV1)

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose

Description

Time Frame

12 weeks

Title

Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks

Description

Time Frame

12 weeks

Title

FEV1 at Individual Time-points

Description

Time Frame

Day 1, Day 29, Day 57 and Days 84/85

Title

Forced Vital Capacity (FVC) at Individual Time-points

Description

Time Frame

Day 1, Day 29, Day 57 and Days 84/85

Title

Inspiratory Capacity (IC) at Individual Time-points

Description

Time Frame

Day 1, Days 84/85

Title

Change From Baseline in Mean Daily Number of Puffs of Rescue Medication

Description

Time Frame

Baseline, 12 weeks

Title

Transitional Dyspnea Index (TDI) Focal Score

Description

Time Frame

baseline, 12 weeks

Title

Change From Baseline in Mean Daily Total and Individual Symptom Scores

Description

Time Frame

Baseline, 12 weeks

Title

Number of Participants With Adverse Events and Serious Adverse Events

Description

All study emergent adverse events including Chronic Obstructive Pulmonary Disease exacerbations were monitored from screening through the end of study.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines. Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 0.70 at screening. Current or ex-smokers who have a smoking history of at least 10 pack years Symptomatic patients according to daily diary data. Exclusion Criteria: Pregnant or nursing (lactating) women. Women of child-bearing potential unless using adequate contraception. Patients with Type I or uncontrolled Type II diabetes. Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged Patients with paroxysmal (e.g. intermittent) atrial fibrillation Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2) Other protocol-defined inclusion/exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gilly

ZIP/Postal Code

6060

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gosselies

ZIP/Postal Code

6041

Country

Belgium

Facility Name

Novartis Investigative Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Herentals

ZIP/Postal Code

2200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Jambes

ZIP/Postal Code

5100

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Luxembourg

ZIP/Postal Code

1210

Country

Belgium

Facility Name

Novartis Investigative Site

City

Malmedy/Bellevaux-Ligneuville

ZIP/Postal Code

4960

Country

Belgium

Facility Name

Novartis Investigative Site

City

Montigny-le-tilleul

ZIP/Postal Code

6110

Country

Belgium

Facility Name

Novartis Investigative Site

City

Turnhout

ZIP/Postal Code

2300

Country

Belgium

Facility Name

Novartis Investigative Site

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

106 76

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

564 03

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1046

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1121

Country

Hungary

Facility Name

Novartis Investigative Site

City

Deszk

ZIP/Postal Code

6772

Country

Hungary

Facility Name

Novartis Investigative Site

City

Erd

ZIP/Postal Code

H-2030

Country

Hungary

Facility Name

Novartis Investigative Site

City

Godollo

ZIP/Postal Code

2100

Country

Hungary

Facility Name

Novartis Investigative Site

City

Wilton

State/Province

Cork

Country

Ireland

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

125315

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

N.Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhny Novgorod

ZIP/Postal Code

603018

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Bardejov

State/Province

Slovak Republic

ZIP/Postal Code

085 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bojnice

State/Province

Slovak Republic

ZIP/Postal Code

972 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Liptovsky Hradok

State/Province

Slovak Republic

ZIP/Postal Code

033 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Námestovo

State/Province

Slovensko

ZIP/Postal Code

02901

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

826 06

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kralovsky Chlmec

ZIP/Postal Code

077 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Gijon

State/Province

Asturias

ZIP/Postal Code

33290

Country

Spain

Facility Name

Novartis Investigative Site

City

Torrelavega

State/Province

Cantabria

ZIP/Postal Code

39300

Country

Spain

Facility Name

Novartis Investigative Site

City

Illescas

State/Province

Castilla la Mancha

ZIP/Postal Code

45200

Country

Spain

Facility Name

Novartis Investigative Site

City

Ponferrada

State/Province

Castilla y Leon

ZIP/Postal Code

24400

Country

Spain

Facility Name

Novartis Investigative Site

City

Centelles

State/Province

Cataluña

ZIP/Postal Code

08540

Country

Spain

Facility Name

Novartis Investigative Site

City

Salt

State/Province

Cataluña

ZIP/Postal Code

17190

Country

Spain

Facility Name

Novartis Investigative Site

City

Sant Boi de Llobregat

State/Province

Cataluña

ZIP/Postal Code

08830

Country

Spain

Facility Name

Novartis Investigative Site

City

Viladecans

State/Province

Cataluña

Country

Spain

Facility Name

Novartis Investigative Site

City

Mérida

State/Province

Extremadura

ZIP/Postal Code

06800

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06490

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34854

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

Country

Turkey

Facility Name

Novartis Investigative Site

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Novartis Investigative Site

City

Mersin

ZIP/Postal Code

33079

Country

Turkey

Facility Name

Novartis Investigative Site

City

Yenisehir/Izmir

ZIP/Postal Code

35110

Country

Turkey

Facility Name

Novartis Investigative Site

City

Burnhope

State/Province

County Durham

ZIP/Postal Code

DH7 0BD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Alderton

State/Province

Suffolk

ZIP/Postal Code

IP12 3DA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Atherstone

State/Province

Warwickshire

ZIP/Postal Code

CV9 1EU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leamington Spa

State/Province

Warwickshire

ZIP/Postal Code

CV32 4RA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Strensall

State/Province

Yorkshire

ZIP/Postal Code

YO32 5UA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bath

ZIP/Postal Code

BA1 2SR

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bexhill-on-Sea

ZIP/Postal Code

TN40 1JJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Blackpool

ZIP/Postal Code

FY3 7EN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bradford

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Cambridge

ZIP/Postal Code

CB7 5JD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Chesterfield

ZIP/Postal Code

S40 4AA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Huntingdon

ZIP/Postal Code

PE29 6NT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Manchester

ZIP/Postal Code

M20 2RN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Newcastle-upon-Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Newton Aycliffe

ZIP/Postal Code

DL5 4SE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Reading

ZIP/Postal Code

RG7 3SQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Southbourne

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Telford

ZIP/Postal Code

TF1 6TF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Watford

ZIP/Postal Code

WD25 0EA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wiltshire

ZIP/Postal Code

SN15 2SB

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

24596459

Citation

Vincken W, Aumann J, Chen H, Henley M, McBryan D, Goyal P. Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study. Int J Chron Obstruct Pulmon Dis. 2014 Feb 24;9:215-28. doi: 10.2147/COPD.S51592. eCollection 2014.

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Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (GLOW6)

Chronic Obstructive Pulmonary Disease (COPD)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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