Comparison of Surgical and Medical Treatment for Congesti... | NCT00023595

Comparison of Surgical and Medical Treatment for Congesti... | NCT00023595 | Trialant

Secondary IDs

ID	Type	Description	Link
U01HL069009	U.S. NIH Grant/Contract		View source
U01HL069010	U.S. NIH Grant/Contract		View source
U01HL069011	U.S. NIH Grant/Contract		View source
U01HL069012	U.S. NIH Grant/Contract		View source
U01HL069013	U.S. NIH Grant/Contract		View source
U01HL069015	U.S. NIH Grant/Contract		View source
U01HL072683	U.S. NIH Grant/Contract		View source
R01HL105853	U.S. NIH Grant/Contract		View source
Pro00010463	Other Identifier	Duke IRB

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Description Module

Detailed Description

BACKGROUND:

Congestive heart failure afflicts approximately five million Americans and is the leading cause of hospitalization in Americans over the age of 65. Most cases of congestive heart failure are due to CAD. Surprisingly little is known about the relative benefits of medical versus surgical therapy for patients with obstructive coronary disease and congestive heart failure. Randomized studies of medical therapy versus bypass surgery for obstructive coronary disease were conducted in the 1970s and did not include the systematic use of aspirin, arterial conduits, or lipid-lowering medications. In addition, patients with ejection fractions below 35% were specifically excluded from the three large randomized studies of medical therapy versus bypass surgery. While observational data from the 1970s and early 1980s suggest a survival advantage associated with bypass surgery in patients with low ejection fraction and congestive heart failure, biases favoring the referral of the fittest of such patients for bypass surgery may have confounded these comparisons. In addition, medical therapy for congestive heart failure has improved dramatically over the past two decades. Thus, the choice of medical therapy versus bypass surgery for patients with congestive heart failure and obstructive coronary disease is usually decided by guesswork. This study is designed to provide a solid answer.

PURPOSE:

STICH is a multicenter, international, randomized trial that addresses two specific primary hypotheses in patients with clinical heart failure (HF) and left ventricular (LV) dysfunction who have coronary artery disease amenable to surgical revascularization.

The first hypothesis is that restoration of blood flow by means of coronary revascularization recovers chronic LV dysfunction and improves survival, as compared to intensive medical therapy alone. The second hypothesis is that surgical ventricular restoration (SVR) to a more normal LV size improves survival free of subsequent hospitalization for cardiac cause compared to CABG alone.

Patients eligible for either medical therapy or CABG, but not eligible for the SVR procedure (Stratum A), will be randomized in equal proportions to medical therapy alone versus CABG plus medical therapy. Patients eligible for all three therapies (Stratum B) will be randomized in equal proportions to medical therapy alone, CABG plus medical therapy, and CABG plus SVR plus medical therapy. Patients whose severity of angina or CAD makes them inappropriate for medical therapy alone (Stratum C) will be randomized in equal proportions to CABG plus medical therapy versus CABG plus SVR plus medical therapy.

The overall target was to recruit 1200 patients into Hypothesis One and 1,000 patients into Hypothesis Two. Secondary endpoints include the role of myocardial viability, morbidity, economics, and quality of life. Core laboratories for quality of life/economics, cardiac magnetic resonance (CMR), echocardiography (ECHO), neurohormonal/cytokine/genetic (NCG), and radionuclide (RN) studies ensure consistent testing practices and standardization of data necessary to identify eligible patients and to address specific questions related to the stated hypotheses.

IMPORTANCE OF RESEARCH:

The most common cause of HF is no longer hypertension or valvular heart disease as it was in previous decades, but rather CAD. HF is a common worldwide disease and CAD is a frequent cause of HF initiation and progression. HF is responsible for approximately 1 million hospitalizations and 300,000 fatalities annually. The prevalence of HF is increasing, largely due to enhanced survival following acute myocardial infarction and other manifestations of CAD. No randomized trial has ever compared directly the long-term benefits of surgical, medical, or combined surgical and medical treatment of patients with ischemic HF. The STICH trial is the first trial to compare the long term benefits of surgical and medical treatment in patients with ischemic HF. Although modern medical therapy for HF modestly improves quality of life, a more aggressive approach with the surgical therapies being studied in the STICH trial may produce even greater improvements. The common clinical practice of not offering CABG to patients with LV dysfunction in regions found to be nonviable on noninvasive studies is not evidence-based. Since only those patients for whom intensive medical therapy is the only reasonable therapeutic alternative are excluded from this study, the results of the STICH trial should be applicable to most patients with CAD, HF, and systolic LV dysfunction. The results of the STICH trial will also establish whether measurements of neurohormonal and cytokine levels and genetic profiling are useful for directing patient management decisions, for monitoring the effectiveness of therapy, and for refining the optimal approach for selecting the treatment strategy most likely to be effective for the many of these patients.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
H01: Medication	Active Comparator	Medical therapy alone to treat Coronary Artery Disease	Drug: Active Medication Alone
H01: Medication + CABG	Active Comparator	Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease	Procedure: CABG surgery plus MED
H02: Medication+CABG	Active Comparator	Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease	Procedure: CABG surgery plus MED
H02: Medication+CABG+SVR	Active Comparator	CABG plus Medication and Surgical ventricular reconstruction (SVR)	Procedure: CABG plus MED and SVR

Name	Type	Description	Arm Group Labels	Other Names
CABG surgery plus MED	Procedure	CABG plus standard medication management for Coronary Artery Disease	H01: Medication + CABG H02: Medication+CABG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
H01: All Cause Mortality		5 years post randomization
H01: All Cause Mortality		10 years post randomization
H02: All-cause Mortality or Cardiovascular Hospitalization		5 years post randomization

Secondary Outcomes

Measure	Description	Time Frame
H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).		10 years post randomization
H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Robert Bonow	Radionuclide Core Lab, Northwestern University	Principal Investigator
Arthur Feldman	Neurohormonal Core Lab, Jefferson University	Principal Investigator
Eric Velazquez, MD	Clinical Coordinating Center, Duke University	Principal Investigator
Kerry Lee	Data Coordinating Center, Duke University	Principal Investigator
Daniel Mark	Economics and Quality of Life Core Lab, Duke University	Principal Investigator
Jae Oh	Echocardiographic Core Lab, Mayo Clinic	Principal Investigator
Gerald Pohost	Magnetic Resonance Imaging Core Lab, University of Southern California	Principal Investigator
Jean Rouleau	Université de Montréal	Study Chair
Julio A Panza, MD	Medstar Health Research Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center		Durham	North Carolina	27715	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18023680	Background	Velazquez EJ, Lee KL, O'Connor CM, Oh JK, Bonow RO, Pohost GM, Feldman AM, Mark DB, Panza JA, Sopko G, Rouleau JL, Jones RH; STICH Investigators. The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. J Thorac Cardiovasc Surg. 2007 Dec;134(6):1540-7. doi: 10.1016/j.jtcvs.2007.05.069.
37716652	Derived	Zhou Z, Jian B, Chen X, Liu M, Zhang S, Fu G, Li G, Liang M, Tian T, Wu Z. Heterogeneous treatment effects of coronary artery bypass grafting in ischemic cardiomyopathy: A machine learning causal forest analysis. J Thorac Cardiovasc Surg. 2024 Nov;168(5):1462-1471.e7. doi: 10.1016/j.jtcvs.2023.09.021. Epub 2023 Sep 15.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	H01: Medication	50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

10 Year Follow up

Type	Comment	Milestone Data
STARTED		FG000602 subjectsall participants who started H01 were counted as starting the 10 year follow up. FG001534 subjectsall participants who started H01 were counted as starting the 10 year follow up. FG00276 subjectsall participants who started H01 were counted as starting the 10 year follow up. FG0030 subjectsH02 arm was not extended and ended at year 5 FG0040 subjectsH02 arm was not extended and ended at year 5
COMPLETED		FG000590 subjects FG001524 subjects FG00273 subjects FG0030 subjectsH02 arm was not extended and ended at year 5
NOT COMPLETED		FG00012 subjects FG00110 subjects FG0023 subjects FG0030 subjects FG004

Type	Comment	Reasons
Lost to Follow-up		FG00012 subjects FG00110 subjects FG0023 subjects FG003

Arm/Group Information

ID	Title	Description
BG000	H01: Medication	50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
BG001	H01: Medication + CABG	50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
BG002	H01+H02: Medication + CABG	This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm.
BG003	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
BG004	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Inter-Quartile Range

years

Title

Denominators

Categories

Title	Measurements
	BG00059(53 to 67) BG00160(54 to 68) BG00261(54 to 68) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00075 BG00164 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

H01: All Cause Mortality

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants	OG000602 OG001610

Title

Denominators

Categories

Title	Measurements
	OG000244 OG001218

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.12		Hazard Ratio (HR)	0.86			2-Sided	95	0.72	1.04			Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)		Superiority or Other (legacy)

Primary

H01: All Cause Mortality

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

10 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants	OG000

Primary

H02: All-cause Mortality or Cardiovascular Hospitalization

The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.
OG001	Total H02: Medication+CABG	H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

10 years post randomization

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units	Counts
Participants

Secondary

H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units	Counts
Participants

Secondary

H01: Mortality or Cardiovascular Hospitalization

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

up to 5 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H01: Mortality or Cardiovascular Hospitalization

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

up to 10 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H02: All-cause Mortality

The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

up to 5 years

ID	Title	Description
OG000	Total H02: Medication+CABG	H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.

Units	Counts
Participants

Secondary

H01: All-cause Mortality Within 30 Days After Randomization

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

30 days post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H02: All-cause Mortality Within 30 Days After Randomization

The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm

Posted

Number

participants

30 days post randomization

ID	Title	Description
OG000	Total H02: Medication+CABG	H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.

Units	Counts
Participants

Secondary

H01: All-cause Mortality or Heart-failure Hospitalization

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H02: All-cause Mortality or Heart-failure Hospitalization

The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	Total H02: Medication+CABG	H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.

Units	Counts
Participants

Secondary

H01: All-cause Mortality or Heart-failure Hospitalization

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

10 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H01: Heart Failure Hospitalization

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H02: Heart Failure Hospitalization

The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	Total H02: Medication+CABG	H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.

Units	Counts
Participants

Secondary

H01: Heart Failure Hospitalization

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

10 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H01: Cardiac Procedure: Heart Transplant

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H02: Cardiac Procedure: Heart Transplant

The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	Total H02: Medication+CABG	H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.

Units	Counts
Participants

Secondary

H01: Cardiac Procedure: Heart Transplant

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

10 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD)

The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	Total H02: Medication+CABG	H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.

Units	Counts
Participants

Secondary

H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

10 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)

The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	Total H02: Medication+CABG	H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.

Units	Counts
Participants

Secondary

H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

10 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H01: Stroke

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants	OG000

Secondary

H01: Stroke

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

10 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants	OG000

Secondary

H02: Stroke

The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	Total H02: Medication+CABG	H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.

Units	Counts
Participants

Secondary

H01: All-cause Mortality or Revascularization (CABG or PCI)

CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts

Secondary

H02: All-cause Mortality or Revascularization (CABG or PCI)

CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.

The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	Total H02: Medication+CABG	H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.

Secondary

H01: All-cause Mortality or Revascularization (CABG or PCI)

CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

10 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts

Secondary

H01: All-cause Mortality, Heart Transplant or LVAD

LVAD=Left Ventricular Assist Device

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H02: All-cause Mortality, Heart Transplant or LVAD

The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	Total H02: Medication+CABG	H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.

Units	Counts
Participants

Secondary

H01: All-cause Mortality, Heart Transplant or LVAD

LVAD=Left Ventricular Assist Device

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

10 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H01: All-cause (Unplanned and Elective) Hospitalization

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H02: All-cause (Unplanned and Elective) Hospitalization

The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

5 years post randomization

ID	Title	Description
OG000	Total H02: Medication+CABG	H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.

Units	Counts
Participants

Secondary

H01: All-cause (Unplanned and Elective) Hospitalization

The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Posted

Number

participants

10 years post randomization

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H01: 6 Minute Walk Distance

Only patients with 6-minute walk distance data at baseline, 4 months or 24 months were analyzed.

Posted

Mean

Standard Deviation

meters

From randomization to 24 month follow-up

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants	OG000

Secondary

H02: 6 Minute Walk Distance

Only patients with 6-minute walk distance data at baseline, 4 months or 24 months were analyzed.

Posted

Mean

Standard Deviation

meters

From randomization to 24 month follow-up

ID	Title	Description
OG000	Total H02: Medication+CABG	H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm.

Units	Counts
Participants

Secondary

H01: Exercise Duration

Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test

Only patients with exercise duration data at baseline or 24 months were analyzed.

Posted

Mean

Standard Deviation

minutes

From randomization to 24 months follow-up

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H02: Exercise Duration

Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test

Only patients with exercise duration data at baseline or 24 months were analyzed.

Posted

Mean

Standard Deviation

meters

From randomization to 24 months follow-up

ID	Title	Description
OG000	Total H02: Medication+CABG
OG001	H02: Medication+CABG+SVR

Units	Counts
Participants	OG000

Secondary

H01: LVEF by ECHO Core Lab During Follow-up

Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab

Only patients with ECHO LVEF data at baseline, 4 months or 24 months were analyzed.

Posted

Mean

Standard Deviation

Percent ejection fraction

From randomization to 24 months follow-up

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H02: LVEF by ECHO Core Lab During Follow-up

Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab

Only patients with ECHO LVEF data at baseline, 4 months or 24 months were analyzed.

Posted

Mean

Standard Deviation

Percent ejection fraction

From randomization to 24 months follow-up

ID	Title	Description
OG000	Total H02: Medication+CABG
OG001	H02: Medication+CABG+SVR

Units	Counts
Participants	OG000

Secondary

H01: LVEF by RN Core Lab During Follow-up

Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.

Only patients with RN LVEF data at Baseline, 4-months or 24-months were analyzed.

Posted

Mean

Standard Deviation

Percent ejection fraction

From randomization to 24 months follow-up

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H02: LVEF by RN Core Lab During Follow-up

Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.

Only patients with RN LVEF data at Baseline, 4-months or 24-months were analyzed.

Posted

Mean

Standard Deviation

Percent ejection fraction

From randomization to 24 months follow-up

ID	Title	Description
OG000	Total H02: Medication+CABG
OG001	H02: Medication+CABG+SVR

Units	Counts
Participants	OG000

Secondary

H01: LVEF by CMR Core Lab During Follow-up

Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.

Only patients with CMR LVEF data at baseline, 4 months or 24 months were analyzed.

Posted

Mean

Standard Deviation

Percent ejection fraction

From randomization to 24 months follow-up

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H02: LVEF by CMR Core Lab During Follow-up

Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.

Only patients with CMR LVEF data at baseline, 4 months or 24 months were analyzed.

Posted

Mean

Standard Deviation

Percent ejection fraction

From randomization to 24 months follow-up

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H01: B-type Natriuretic Peptide (BNP)

B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up

Only patients with BNP data at baseline or 4 months were analyzed.

Posted

Mean

Standard Deviation

pg/mL

From randomization to 24 months follow-up

ID	Title	Description
OG000	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.
OG001	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.

Units	Counts
Participants

Secondary

H02: B-type Natriuretic Peptide (BNP)

B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up

Only patients with BNP data at baseline or 4 months were analyzed.

Posted

Mean

Standard Deviation

pg/mL

From randomization to 24 months follow-up

ID	Title	Description
OG000	Total H02: Medication+CABG
OG001	H02: Medication+CABG+SVR

Units	Counts
Participants	OG000386

Secondary

H01: SF-36 Mental Health Subscale

Short Form 36 Health Status Questionnaire (SF-36) Mental Health Subscale: These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Secondary

H02: SF-36 Mental Health Subscale

These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Secondary

H01:SF-36 Role Physical Subscale

These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Secondary

H02: SF-36 Role Physical Subscale

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Secondary

H01:SF-36 Role Emotional Subscale

These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Secondary

H02: SF-36 Role Emotional Subscale

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Secondary

H01:SF-36 Social Functioning Subscale

These 2 items assess the limitations on social activities with others. Response choices range from "Extremely" or "All of the time" (1) to "Not at all" or "None of the time" (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Secondary

H02: SF-36 Social Functioning Subscale

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Secondary

H01:SF-36 Vitality Subscale

These 4 items assess energy level and fatigue. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units

Secondary

H02: SF-36 Vitality Subscale

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units

Secondary

H01:SF-12 Physical Component Summary (PCS) Scale

Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "physical" regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "physical" constant from the scoring table to the sum of the 35 products.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Secondary

H02: SF-12 Physical Component Summary (PCS) Scale

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Secondary

H01: SF-12 Mental Component Summary (MCS) Scale

Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "mental" regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "mental" constant from the scoring table to the sum of the 35 products.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Secondary

H02: SF-12 Mental Component Summary (MCS) Scale

Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "mental" regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "mental" constant from the scoring table to the sum of the 35 products.

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Secondary

H01: KCCQ Physical Limitation Scale

Kansas City Cardiomyopathy Questionnaire (KCCQ)Physical Limitation Scale: These 6 items assess ability to perform various activities of daily living. Response choices range from "Extremely limited" (1) to "Not at all limited" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Secondary

H02: KCCQ Physical Limitation Scale

These 6 items assess ability to perform various activities of daily living. Response choices range from "Extremely limited" (1) to "Not at all limited" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units	Counts

Secondary

H01: KCCQ Symptom Stability

This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from "Much worse" (1) to "Much better" (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units	Counts

Secondary

H02: KCCQ Symptom Stability

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units	Counts

Secondary

H01: KCCQ Symptom Frequency

These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from "Every morning" or "Every night" or "All of the time" (1) to "Never over the past 2 weeks" (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Secondary

H02: KCCQ Symptom Frequency

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Secondary

H01: KCCQ Symptom Burden

These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from "extremely bothersome" (1) to "Not at all bothersome" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units

Secondary

H02: KCCQ Symptom Burden

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units

Secondary

H01: KCCQ Total Symptoms

This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units	Counts
Participants

Secondary

H02: KCCQ Total Symptoms

This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units	Counts
Participants

Secondary

H01: KCCQ Quality-of-Life Scale

These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units	Counts

Secondary

H02: KCCQ Quality-of-Life Scale

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units	Counts

Secondary

H01: KCCQ Social Limitation

These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from "Severely limited" (1) to "Did not limit at all" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units	Counts

Secondary

H02: KCCQ Social Limitation

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units	Counts

Secondary

H01: KCCQ Clinical Summary Score

This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units	Counts
Participants

Secondary

H02: KCCQ Clinical Summary Score

This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units	Counts
Participants

Secondary

H01: KCCQ Overall Summary Score

This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units	Counts

Secondary

H02: KCCQ Overall Summary Score

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units	Counts

Secondary

H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale

These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from "4 or more times a day" (1) to "None" (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units	Counts

Secondary

H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units	Counts

Secondary

H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale

This item assesses the change in chest pain over the last 4 weeks. Response choices range from "Much more often" (1) to "None" (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units

Secondary

H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units	Counts

Secondary

H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale

These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units	Counts

Secondary

H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units	Counts

Secondary

H01: EQ-5D Visual Analog Scale

Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D): This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units	Counts
Participants

Secondary

H02: EQ-5D Visual Analog Scale

This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units	Counts
Participants

Secondary

H01: EQ-5D Health Status Index Score

This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are "No problems" (1), "Moderate problems" (2), or "Extreme problems" (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. These scores were multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Secondary

H02: EQ-5D Health Status Index Score

This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are "No problems" (1), "Moderate problems" (2), or "Extreme problems" (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. (These scores can be multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.)

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Secondary

H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale

These 20 items assess depressive symptomatology, and responses choices range from "Rarely or none of the time" (0) to "Most or all of the time" (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high.

Only patients with questionnaire data were analyzed.

Posted

Number

percentage of participants

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Secondary

H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale

Only patients with questionnaire data were analyzed.

Posted

Number

percentage of participants

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Secondary

H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale

These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Secondary

H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units

Secondary

H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale

These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Secondary

H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Secondary

H01: General Health Rating Scale

This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.

Only patients with questionnaire data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	Total H01: Medication + CABG	H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm.
OG001	H01: Medication	H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm.

Units	Counts
Participants

Secondary

H02: General Health Rating Scale

This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.

Only patients with questionnaire data were analyzed.

Posted

Median

Inter-Quartile Range

units on a scale

From enrollment to 3-year follow-up

ID	Title	Description
OG000	H02: Medication+CABG	50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02.
OG001	H02: Medication+CABG+SVR	50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm

Units	Counts
Participants

Secondary

H01: Cost of Care

Hospital costs and physician fees for US patients

US patients with hospital bills

Posted

Mean

Standard Deviation

2009 US Dollars

index hospital admission

ID	Title	Description
OG000	H01: Medication + CABG	Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease CABG surgery plus MED (medication): CABG plus standard medication management for Coronary Artery Disease
OG001	H01: Medication	Medical therapy alone to treat Coronary Artery Disease Active Medication Alone: Standard medication for coronary artery disease and heart failure management.

Units	Counts
Participants	OG000

Secondary

H02: Cost of Care

Hospital costs and physician fees for US patients

US patients with hospital bills

Posted

Mean

Standard Deviation

2008 US Dollars

index hospital admission

ID	Title	Description
OG000	H02: Medication+CABG	Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease CABG surgery plus MED: CABG plus standard medication management for Coronary Artery Disease
OG001	H02: Medication+CABG+SVR	CABG plus Medication and Surgical ventricular reconstruction (SVR) CABG plus MED and SVR: H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Serious Events (Affected)	Serious Events (At Risk)
EG000	H01: Medication	84	602
EG001	H01: Medication + CABG	85	534
EG002	H01 & H02: Medication+CABG	9	76
EG003	H02: Medication+CABG	31	423
EG004	H02: Medication+CABG+SVR	53	501

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
ABSCESS	Infections and infestations	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG0030 affected423 at risk EG0041 affected501 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
ACUTE HEART FAILURE	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
ACUTE LEFT VENTRICULAR FAILURE	Cardiac disorders	Non-systematic Assessment	EG0002 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0014 affected534 at risk EG0020 affected76 at risk EG003
ACUTE PULMONARY EDEMA	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
ACUTE RENAL FAILURE	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0017 affected534 at risk EG0021 affected76 at risk EG003
ACUTE RESPIRATORY INSUFFICIENCY	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
ALS	Nervous system disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
ANGINA PECTORIS	Cardiac disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
ANGINAL DISCOMFORT	Cardiac disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
ANGIOEDEMA	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
ANOXIC ENCEPHALOPATHY	Nervous system disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
AORTIC RUPTURE	Vascular disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
ARRHYTHMIA	Cardiac disorders	Non-systematic Assessment	EG0006 affected602 at risk EG0017 affected534 at risk EG0020 affected76 at risk EG003
ARTERIAL EMBOLISM (LIMBS)	Vascular disorders	Non-systematic Assessment	EG0004 affected602 at risk EG0013 affected534 at risk EG0020 affected76 at risk EG003
ASCITES	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
ASPIRATION PNEUMONIA	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
ASYSTOLIA	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
BACTEREMIA	Infections and infestations	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
BOWEL ISCHEMIA	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
BRAIN TUMOR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
BRONCHITIS	Infections and infestations	Non-systematic Assessment	EG0002 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
BUN INCREASED	Investigations	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
CANCER OF LUNG	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
CARDIAC ARREST	Cardiac disorders	Non-systematic Assessment	EG0005 affected602 at risk EG0015 affected534 at risk EG0020 affected76 at risk EG003
CARDIAC ARRHYTHMIA	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
CARDIAC CIRRHOSIS	Hepatobiliary disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
CARDIAC DISORDER	Cardiac disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
CARDIAC FAILURE	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
CARDIAC FAILURE ACUTE	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
CARDIAC FAILURE AGGRAVATED	Cardiac disorders	Non-systematic Assessment	EG0002 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
CARDIAC TAMPONADE	Cardiac disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
CARDIAC VENTRICULAR THROMBOSIS	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0021 affected76 at risk EG003
CARDIOGENIC SHOCK	Cardiac disorders	Non-systematic Assessment	EG0003 affected602 at risk EG0013 affected534 at risk EG0020 affected76 at risk EG003
CARDIOPULMONARY INSUFFICIENCY	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
CARDIOVASCULAR INSUFFICIENCY	Cardiac disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
CHRONIC SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
CLAUDICATION	Vascular disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
CMV INFECTION	Infections and infestations	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
CONFUSION	Psychiatric disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
CONGESTIVE CARDIAC FAILURE	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
CONGESTIVE HEART FAILURE	Cardiac disorders	Non-systematic Assessment	EG0003 affected602 at risk EG0012 affected534 at risk EG0020 affected76 at risk EG003
CORONARY OCCLUSION	Cardiac disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
CREATININE INCREASED	Investigations	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
CYSTITIS	Infections and infestations	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
DECOMPENSATED HEART FAILURE	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
DECOMPENSATION CARDIAC	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
DEVICE LEAD ISSUE	General disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
DIARRHEA	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
DYSPNEA	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
EDEMA	General disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
EDEMA PULMONARY	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
EMBOLIC CEREBRAL INFARCTION	Nervous system disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
END STAGE CARDIAC FAILURE	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0021 affected76 at risk EG003
GALLSTONES	Hepatobiliary disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
GASTRIC ULCER PERFORATED	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
GASTROINTESTINAL NECROSIS	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
GOUT	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
HAEMODYNAMIC INSTABILITY	Vascular disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
HEART FAILURE	Cardiac disorders	Non-systematic Assessment	EG00011 affected602 at risk EG0016 affected534 at risk EG0021 affected76 at risk EG003
HEMODYNAMIC INSTABILITY	Vascular disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
HEMORRHAGE BRAIN	Nervous system disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
HEPARIN-INDUCED THROMBOCYTOPENIA	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
HEPATIC INSUFFICIENCY	Hepatobiliary disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
HEPATOMEGALY	Hepatobiliary disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
HERNIA	General disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
HOSPITALIZATION NOS	Surgical and medical procedures	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
HYPERKALEMIA	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
HYPERTHYROIDISM	Endocrine disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
HYPOKALEMIA	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
HYPOTENSION	Vascular disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
HYPOVOLEMIA	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
IMPLANT SITE INFECTION	Infections and infestations	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
INFECTED SKIN ULCER	Infections and infestations	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
INFECTION	Infections and infestations	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
INSUFFICIENCY CARDIAC	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
ISCHEMIC CARDIOMYOPATHY	Cardiac disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
JAUNDICE	Hepatobiliary disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
LEFT VENTRICULAR FAILURE	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
LEUKOCYTOSIS	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
LOSS OF CONSCIOUSNESS	Nervous system disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
LOW BLOOD PRESSURE	Vascular disorders	Non-systematic Assessment	EG0002 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
LOW CARDIAC OUTPUT SYNDROME	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
MALIGNANT VENTRICULAR ARRHYTHMIAS	Cardiac disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
MEDIASTINAL HEMORRHAGE	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
MEDIASTINITIS	Infections and infestations	Non-systematic Assessment	EG0000 affected602 at risk EG0014 affected534 at risk EG0020 affected76 at risk EG003
MESOTHELIOMA MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
MITRAL VALVE DISEASE	Cardiac disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
MULTI ORGAN FAILURE	General disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
MULTIORGAN FAILURE	General disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
MULTIPLE ORGAN FAILURE	General disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0021 affected76 at risk EG003
MYELODYSPLASTIC SYNDROME	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	Non-systematic Assessment	EG0002 affected602 at risk EG0013 affected534 at risk EG0020 affected76 at risk EG003
MYOPATHY	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
NECROSIS SKIN	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
NECROTIZING FASCIITIS	Infections and infestations	Non-systematic Assessment	EG0001 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
OTHER CARDIAC	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
PAROXYSMAL ATRIAL FIBRILLATION	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
PERICARDIAL EFFUSION	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
PERIPHERAL VASCULAR DISEASE	Vascular disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0012 affected534 at risk EG0020 affected76 at risk EG003
PNEUMONIA	Infections and infestations	Non-systematic Assessment	EG0001 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
POSTOPERATIVE HEMORRHAGE	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
POSTPERICARDIOTOMY SYNDROME	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
PULMONARY ARTERY THROMBOSIS	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
PULMONARY EDEMA	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
PULMONARY EMBOLUS	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
PULMONARY THROMBOEMBOLISM	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
PULSELESS ELECTRICAL ACTIVITY	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
RENAL FAILURE	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
RENAL INSUFFICIENCY	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
RESPIRATORY INSUFFICIENCY	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
SCLERODERMA	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
SEPSIS	Infections and infestations	Non-systematic Assessment	EG0001 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
SEPTIC SHOCK	Infections and infestations	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
SHORTNESS OF BREATH	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
SIRS	General disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
SKIN TROPHIC ULCER	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
STERNAL DEHISCENCE	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected602 at risk EG0012 affected534 at risk EG0020 affected76 at risk EG003
STROKE	Nervous system disorders	Non-systematic Assessment	EG00017 affected602 at risk EG00116 affected534 at risk EG0022 affected76 at risk EG003
SUPERFICIAL PHLEBOTHROMBOSIS	Vascular disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
SUSTAINED VENTRICULAR TACHYCARDIA	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0021 affected76 at risk EG003
SVT	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0011 affected534 at risk EG0020 affected76 at risk EG003
TACHYCARDIA	Cardiac disorders	Non-systematic Assessment	EG0000 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
UNSTABLE ANGINA	Cardiac disorders	Non-systematic Assessment	EG0002 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
UPPER GASTROINTESTINAL HEMORRHAGE	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
VENTRICULAR ARRHYTHMIA	Cardiac disorders	Non-systematic Assessment	EG0002 affected602 at risk EG0014 affected534 at risk EG0020 affected76 at risk EG003
VENTRICULAR FIBRILLATION	Cardiac disorders	Non-systematic Assessment	EG0006 affected602 at risk EG0013 affected534 at risk EG0022 affected76 at risk EG003
VENTRICULAR TACHYCARDIA	Cardiac disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
VERTIGO	Ear and labyrinth disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
VOLUME OVERLOAD	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003
VOMITING	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected602 at risk EG0010 affected534 at risk EG0020 affected76 at risk EG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.02		Hazard Ratio (HR)	0.84			2-Sided	95	0.73	0.97			Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.90		Hazard Ratio (HR)	0.99			2-Sided	95	0.84	1.17			Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.006		Hazard Ratio, log	0.79			2-Sided	95	0.66	0.93			Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.05		Hazard Ratio (HR)	0.81			2-Sided	95	0.66	1.00			Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		<0.001		Hazard Ratio (HR)	0.74			2-Sided	95	0.64	0.85			Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		<0.001		Hazard Ratio (HR)	0.72			2-Sided	95	0.64	0.82			Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.98		Hazard Ratio (HR)	1.00			2-Sided	95	0.79	1.26			Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		0.008		Odds Ratio (OR)	3.19			2-Sided	95	1.35	7.52			Odds Ratio is for (H01: Medication +CABG) versus (H01: Medication)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		0.275		Odds Ratio (OR)	1.37			2-Sided	95	0.78	2.41			Odds Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.030		Hazard Ratio (HR)	0.84			2-Sided	95	0.71	0.98			Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.401		Hazard Ratio (HR)	1.08			2-Sided	95	0.89	1.31			Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.002		Hazard Ratio (HR)	0.81			2-Sided	95	0.71	0.93			Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		<0.001		Hazard Ratio (HR)	0.60			2-Sided	95	0.51	0.71			Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.414		Hazard Ratio (HR)	0.91			2-Sided	95	0.73	1.13			Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		<0.001		Hazard Ratio (HR)	0.63			2-Sided	95	0.55	0.73			Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.108		Hazard Ratio (HR)	0.86			2-Sided	95	0.72	1.03			Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.717		Hazard Ratio (HR)	1.05			2-Sided	95	0.83	1.32			Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.018		Hazard Ratio (HR)	0.84			2-Sided	95	0.73	0.97			Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)		Superiority or Other (legacy)

Title

Denominators

Categories

Baseline

- ParticipantsOG000535
- ParticipantsOG001506

Title	Measurements
	OG000333.97± 117.76 OG001333.04± 117.06

4 month

- ParticipantsOG000442
- ParticipantsOG001404

Title	Measurements
	OG000364.25± 111.24 OG001

Changed from baseline to 4 months

- ParticipantsOG000420
- ParticipantsOG001368

Title	Measurements
	OG00028.2± 102.44 OG001

24 month

- ParticipantsOG000301
- ParticipantsOG001296

Title	Measurements
	OG000381.55± 120.86 OG001

Change from baseline to 24 Months

- ParticipantsOG000287
- ParticipantsOG001264

Title	Measurements
	OG00034.11± 112.9 OG001

Title

Denominators

Categories

Baseline

- ParticipantsOG000335
- ParticipantsOG001357

Title	Measurements
	OG000339.38± 126.11 OG001357.23± 116.91

4 month

- ParticipantsOG000335
- ParticipantsOG001341

Title	Measurements
	OG000385.89± 123.49 OG001

Changed from baseline to 4 months

- ParticipantsOG000259
- ParticipantsOG001273

Title	Measurements
	OG00044.42± 122.64 OG001

24 month

- ParticipantsOG000256
- ParticipantsOG001248

Title	Measurements
	OG000400.66± 121.67 OG001

Change from baseline to 24 Months

- ParticipantsOG000196
- ParticipantsOG001206

Title	Measurements
	OG00051.51± 125.65 OG001

Title

Denominators

Categories

Baseline

- ParticipantsOG000256
- ParticipantsOG001230

Title	Measurements
	OG0006.85± 3.4 OG0016.3± 3.39

24 month

- ParticipantsOG000118
- ParticipantsOG001117

Title	Measurements
	OG0007.78± 3.32 OG001

Change from baseline to 24 Months

- ParticipantsOG000105
- ParticipantsOG001105

Title	Measurements
	OG0000.71± 3.51 OG001

Title

Denominators

Categories

Baseline

- ParticipantsOG000106
- ParticipantsOG001127

Title	Measurements
	OG0006.19± 3.42 OG0017.16± 3.47

24 month

- ParticipantsOG00062
- ParticipantsOG00167

Title	Measurements
	OG0007.67± 3.3 OG001

Change from baseline to 24 Months

- ParticipantsOG00049
- ParticipantsOG00156

Title	Measurements
	OG0001.15± 3.01 OG001

Title

Denominators

Categories

Baseline

- ParticipantsOG000566
- ParticipantsOG001558

Title	Measurements
	OG00028.69± 8.33 OG00128.43± 8.24

4 month

- ParticipantsOG000461
- ParticipantsOG001436

Title	Measurements
	OG00030.83± 9.41 OG001

Changed from baseline to 4 months

- ParticipantsOG000447
- ParticipantsOG001410

Title	Measurements
	OG0002.21± 8.8 OG001

24 month

- ParticipantsOG000327
- ParticipantsOG001320

Title	Measurements
	OG00031.39± 10.75 OG001

Change from baseline to 24 Months

- ParticipantsOG000319
- ParticipantsOG001301

Title	Measurements
	OG0002.2± 11.31 OG001

Title

Denominators

Categories

Baseline

- ParticipantsOG000464
- ParticipantsOG001464

Title	Measurements
	OG00029.13± 7.74 OG00129.49± 8.23

4 month

- ParticipantsOG000378
- ParticipantsOG001359

Title	Measurements
	OG00031.47± 10.4 OG001

Changed from baseline to 4 months

- ParticipantsOG000361
- ParticipantsOG001341

Title	Measurements
	OG0002.16± 10.23 OG001

24 month

- ParticipantsOG000289
- ParticipantsOG001275

Title	Measurements
	OG00031.89± 11.38 OG001

Change from baseline to 24 Months

- ParticipantsOG000277
- ParticipantsOG001264

Title	Measurements
	OG0002.24± 11.11 OG001

Title

Denominators

Categories

Baseline

- ParticipantsOG000241
- ParticipantsOG001242

Title	Measurements
	OG00026.83± 8.66 OG00126.66± 8.41

4 month

- ParticipantsOG00056
- ParticipantsOG00155

Title	Measurements
	OG00027.2± 9.5 OG001

Changed from baseline to 4 months

- ParticipantsOG00050
- ParticipantsOG00144

Title	Measurements
	OG0000.99± 5.88 OG001

24 month

- ParticipantsOG00026
- ParticipantsOG00128

Title	Measurements
	OG00030.65± 10.74 OG001

Change from baseline to 24 Months

- ParticipantsOG00021
- ParticipantsOG00123

Title	Measurements
	OG0003.99± 8.24 OG001

Title

Denominators

Categories

Baseline

- ParticipantsOG000168
- ParticipantsOG001182

Title	Measurements
	OG00027.14± 8.18 OG00126.55± 7.83

4 month

- ParticipantsOG000132
- ParticipantsOG001148

Title	Measurements
	OG00030.65± 10.41 OG001

Changed from baseline to 4 months

- ParticipantsOG00098
- ParticipantsOG001123

Title	Measurements
	OG0002.23± 7.11 OG001

24 month

- ParticipantsOG00095
- ParticipantsOG00195

Title	Measurements
	OG00029.95± 10.97 OG001

Change from baseline to 24 Months

- ParticipantsOG00069
- ParticipantsOG00178

Title	Measurements
	OG0002.01± 9.58 OG001

Title

Denominators

Categories

Baseline

- ParticipantsOG00046
- ParticipantsOG00164

Title	Measurements
	OG00029.51± 11.02 OG00123.35± 9.49

4 month

- ParticipantsOG00025
- ParticipantsOG00127

Title	Measurements
	OG00028.6± 11.11 OG001

Changed from baseline to 4 months

- ParticipantsOG00021
- ParticipantsOG00124

Title	Measurements
	OG0000.07± 8.82 OG001

24 month

- ParticipantsOG00011
- ParticipantsOG00112

Title	Measurements
	OG00032.72± 14.7 OG001

Change from baseline to 24 Months

- ParticipantsOG00010
- ParticipantsOG00110

Title	Measurements
	OG000-1.09± 10.63 OG001

Title

Denominators

Categories

Baseline

- ParticipantsOG000184
- ParticipantsOG001171

Title	Measurements
	OG00027.82± 10.26 OG00127.25± 11.47

4 month

- ParticipantsOG000120
- ParticipantsOG001115

Title	Measurements
	OG00031.65± 13.53 OG001

Changed from baseline to 4 months

- ParticipantsOG000101
- ParticipantsOG00197

Title	Measurements
	OG0002.84± 11.86 OG001

24 month

- ParticipantsOG00050
- ParticipantsOG00160

Title	Measurements
	OG00028.46± 10.57 OG001

Change from baseline to 24 Months

- ParticipantsOG00040
- ParticipantsOG00148

Title	Measurements
	OG000-0.51± 14.61 OG001

Title

Denominators

Categories

Baseline

- ParticipantsOG000297
- ParticipantsOG001310

Title	Measurements
	OG000497.29± 627.49 OG001478.73± 521.11

4 month

- ParticipantsOG000259
- ParticipantsOG001249

Title	Measurements
	OG000408.69± 413.27 OG001

Changed from baseline to 4 months

- ParticipantsOG000242
- ParticipantsOG001234

Title	Measurements
	OG000-20.65± 405.44 OG001

Title

Denominators

Categories

Baseline

- ParticipantsOG000386
- ParticipantsOG001392

Title	Measurements
	OG000453.73± 563.1 OG001452.45± 665.06

4 month

- ParticipantsOG000296
- ParticipantsOG001306

Title	Measurements
	OG000460.14± 508.35 OG001

Changed from baseline to 4 months

- ParticipantsOG000276
- ParticipantsOG001285

Title	Measurements
	OG00019.75± 600.26 OG001

Title

Denominators

Categories

Baseline

- ParticipantsOG000597
- ParticipantsOG001584

Title	Measurements
	OG00043.7± 11.8 OG00144.4± 11.8

4 Months

- ParticipantsOG000503
- ParticipantsOG001521

Title	Measurements
	OG00048.2± 10.2 OG001

12 Months

- ParticipantsOG000456
- ParticipantsOG001454

Title	Measurements
	OG00048.8± 11.1 OG001

24 Months

- ParticipantsOG000398
- ParticipantsOG001403

Title	Measurements
	OG00048.6± 10.5 OG001

36 Months

- ParticipantsOG000392
- ParticipantsOG001372

Title	Measurements
	OG00048.5± 11.1 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.015	4 months	Superiority
OG000 OG001	Chi-squared		0.002	12 months	Superiority
OG000 OG001	Chi-squared		0.011	24 months	Superiority
OG000 OG001	Chi-squared		0.44	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000489
- ParticipantsOG001481

Title	Measurements
	OG00041(32 to 50) OG00141(35 to 50)

4 Months

- ParticipantsOG000410
- ParticipantsOG001407

Title	Measurements
	OG00050(39 to 57) OG001

12 Months

- ParticipantsOG000380
- ParticipantsOG001389

Title	Measurements
	OG00053(44 to 60) OG001

24 Months

- ParticipantsOG000345
- ParticipantsOG001347

Title	Measurements
	OG00050(41 to 57) OG001

36 Months

- ParticipantsOG000310
- ParticipantsOG001313

Title	Measurements
	OG00050(41 to 60) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.91	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.62	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.04	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.96		Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.78		Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000581
- ParticipantsOG001569

Title	Measurements
	OG00036.1± 10.9 OG00136.6± 11.2

4 Months

- ParticipantsOG000486
- ParticipantsOG001508

Title	Measurements
	OG00043.0± 11.8 OG001

12 Months

- ParticipantsOG000445
- ParticipantsOG001446

Title	Measurements
	OG00045.7± 11.4 OG001

24 Months

- ParticipantsOG000396
- ParticipantsOG001394

Title	Measurements
	OG00046.6± 11.4 OG001

36 Months

- ParticipantsOG000388
- ParticipantsOG001368

Title	Measurements
	OG00046.0± 11.2 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.31	4 months	Superiority
OG000 OG001	Chi-squared		0.002	12 months	Superiority
OG000 OG001	Chi-squared		0.028		Superiority	24 months
OG000 OG001	Chi-squared		0.079	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000466
- ParticipantsOG001466

Title	Measurements
	OG00028(28 to 35) OG00128(28 to 42)

4 Months

- ParticipantsOG000400
- ParticipantsOG001393

Title	Measurements
	OG00042(28 to 56) OG001

12 Months

- ParticipantsOG000372
- ParticipantsOG001389

Title	Measurements
	OG00049(35 to 56) OG001

24 Months

- ParticipantsOG000340
- ParticipantsOG001339

Title	Measurements
	OG00049(28 to 56) OG001

36 Months

- ParticipantsOG000308
- ParticipantsOG001309

Title	Measurements
	OG00049(35 to 56) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.74	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.61	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.78		Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.94	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.29	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000588
- ParticipantsOG001582

Title	Measurements
	OG00039.0± 14.2 OG00140.0± 14.4

4 Months

- ParticipantsOG000499
- ParticipantsOG001511

Title	Measurements
	OG00045.3± 13.2 OG001

12 Months

- ParticipantsOG000455
- ParticipantsOG001450

Title	Measurements
	OG00046.4± 12.8 OG001

24 Months

- ParticipantsOG000398
- ParticipantsOG001396

Title	Measurements
	OG00047.5± 12.1 OG001

36 Months

- ParticipantsOG000392
- ParticipantsOG001364

Title	Measurements
	OG00048.0± 11.8 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.063	4 months	Superiority
OG000 OG001	Chi-squared		0.187	12 months	Superiority
OG000 OG001	Chi-squared		0.168	24 months	Superiority
OG000 OG001	Chi-squared		0.050	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000482
- ParticipantsOG001477

Title	Measurements
	OG00034(24 to 55) OG00134(24 to 55)

4 Months

- ParticipantsOG000409
- ParticipantsOG001402

Title	Measurements
	OG00055(34 to 55) OG001

12 Months

- ParticipantsOG000377
- ParticipantsOG001384

Title	Measurements
	OG00055(45 to 55) OG001

24 Months

- ParticipantsOG000341
- ParticipantsOG001344

Title	Measurements
	OG00055(45 to 55) OG001

36 Months

- ParticipantsOG000306
- ParticipantsOG001308

Title	Measurements
	OG00055(45 to 55) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.82	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.48	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.69	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.63	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.90	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000601
- ParticipantsOG001588

Title	Measurements
	OG00041.8± 12.0 OG00142.1± 12.0

4 Months

- ParticipantsOG000505
- ParticipantsOG001523

Title	Measurements
	OG00047.0± 11.1 OG001

12 Months

- ParticipantsOG000457
- ParticipantsOG001456

Title	Measurements
	OG00048.7± 10.4 OG001

24 Months

- ParticipantsOG000401
- ParticipantsOG001403

Title	Measurements
	OG00048.3± 9.9 OG001

36 Months

- ParticipantsOG000394
- ParticipantsOG001370

Title	Measurements
	OG00047.8± 10.3 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.039	4 months	Superiority
OG000 OG001	Chi-squared		0.002	12 months	Superiority
OG000 OG001	Chi-squared		0.008	24 months	Superiority
OG000 OG001	Chi-squared		0.31	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000490
- ParticipantsOG001485

Title	Measurements
	OG00041(30 to 52) OG00135(30 to 46)

4 Months

- ParticipantsOG000410
- ParticipantsOG001411

Title	Measurements
	OG00052(35 to 57) OG001

12 Months

- ParticipantsOG000380
- ParticipantsOG001389

Title	Measurements
	OG00052(41 to 57) OG001

24 Months

- ParticipantsOG000345
- ParticipantsOG001349

Title	Measurements
	OG00052(41 to 57) OG001

36 Months

- ParticipantsOG000308
- ParticipantsOG001313

Title	Measurements
	OG00052(41 to 57) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.36	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.87	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.17	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.12	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.79	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000598
- ParticipantsOG001586

Title	Measurements
	OG00046.4± 10.3 OG00147.5± 10.9

4 Months

- ParticipantsOG000503
- ParticipantsOG001522

Title	Measurements
	OG00051.6± 9.8 OG001

12 Months

- ParticipantsOG000456
- ParticipantsOG001453

Title	Measurements
	OG00052.2± 10.1 OG001

24 Months

- ParticipantsOG000398
- ParticipantsOG001403

Title	Measurements
	OG00051.9± 9.9 OG001

36 Months

- ParticipantsOG000393
- ParticipantsOG001372

Title	Measurements
	OG00051.4± 10.0 OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	<0.001	4 months	Superiority
OG000 OG001	Chi-squared	<0.001	12 months	Superiority
OG000 OG001	Chi-squared	<0.001	24 months	Superiority
OG000 OG001	Chi-squared	<0.024	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000489
- ParticipantsOG001480

Title	Measurements
	OG00044(37 to 51) OG00144(37 to 49)

4 Months

- ParticipantsOG000410
- ParticipantsOG001409

Title	Measurements
	OG00051(42 to 59) OG001

12 Months

- ParticipantsOG000380
- ParticipantsOG001390

Title	Measurements
	OG00053(44 to 59) OG001

24 Months

- ParticipantsOG000345
- ParticipantsOG001347

Title	Measurements
	OG00051(44 to 59) OG001

36 Months

- ParticipantsOG000309
- ParticipantsOG001313

Title	Measurements
	OG00051(44 to 59) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.31	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.42	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.66	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.32	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.43	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000534
- ParticipantsOG001530

Title	Measurements
	OG00037.8± 6.1 OG00138.4± 5.7

4 Months

- ParticipantsOG000448
- ParticipantsOG001455

Title	Measurements
	OG00040.2± 5.9 OG001

12 Months

- ParticipantsOG000403
- ParticipantsOG001405

Title	Measurements
	OG00041.0± 5.3 OG001

24 Months

- ParticipantsOG000370
- ParticipantsOG001356

Title	Measurements
	OG00041.3± 5.7 OG001

36 Months

- ParticipantsOG000347
- ParticipantsOG001333

Title	Measurements
	OG00040.8± 5.5 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.051	4 months	Superiority
OG000 OG001	Chi-squared		0.003	12 months	Superiority
OG000 OG001	Chi-squared		0.065	24 months	Superiority
OG000 OG001	Chi-squared		0.83	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000433
- ParticipantsOG001426

Title	Measurements
	OG00037(33 to 41) OG00137(33 to 41)

4 Months

- ParticipantsOG000353
- ParticipantsOG001352

Title	Measurements
	OG00040(36 to 43) OG001

12 Months

- ParticipantsOG000343
- ParticipantsOG001336

Title	Measurements
	OG00041(37 to 43) OG001

24 Months

- ParticipantsOG000303
- ParticipantsOG001301

Title	Measurements
	OG00041(37 to 44) OG001

36 Months

- ParticipantsOG000278
- ParticipantsOG001277

Title	Measurements
	OG00040(36 to 44) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.71	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.57	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.15	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.64	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.07	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000534
- ParticipantsOG001530

Title	Measurements
	OG00044.6± 12.6 OG00145.5± 13.0

4 Months

- ParticipantsOG000448
- ParticipantsOG001455

Title	Measurements
	OG00050.5± 11.8 OG001

12 Months

- ParticipantsOG000403
- ParticipantsOG001405

Title	Measurements
	OG00051.8± 12.1 OG001

24 Months

- ParticipantsOG000370
- ParticipantsOG001356

Title	Measurements
	OG00051.6± 11.1 OG001

36 Months

- ParticipantsOG000347
- ParticipantsOG001333

Title	Measurements
	OG00051.6± 11.4 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.004	4 months	Superiority
OG000 OG001	Chi-squared		0.011	12 months	Superiority
OG000 OG001	Chi-squared		0.007	24 months	Superiority
OG000 OG001	Chi-squared		0.044	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000433
- ParticipantsOG001426

Title	Measurements
	OG00042(32 to 53) OG00141(33 to 53)

4 Months

- ParticipantsOG000353
- ParticipantsOG001352

Title	Measurements
	OG00054(41 to 62) OG001

12 Months

- ParticipantsOG000343
- ParticipantsOG001336

Title	Measurements
	OG00057(46 to 63) OG001

24 Months

- ParticipantsOG000303
- ParticipantsOG001301

Title	Measurements
	OG00056(44 to 61) OG001

36 Months

- ParticipantsOG000278
- ParticipantsOG001277

Title	Measurements
	OG00056(45 to 62) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.74	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.87	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.03	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.60	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.87	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000597
- ParticipantsOG001585

Title	Measurements
	OG00064.2± 24.7 OG00164.7± 26.1

4 Months

- ParticipantsOG000511
- ParticipantsOG001527

Title	Measurements
	OG00075.2± 23.6 OG001

12 Months

- ParticipantsOG000472
- ParticipantsOG001464

Title	Measurements
	OG00077.8± 23.0 OG001

24 Months

- ParticipantsOG000410
- ParticipantsOG001412

Title	Measurements
	OG00076.6± 23.1 OG001

36 Months

- ParticipantsOG000404
- ParticipantsOG001385

Title	Measurements
	OG00076.8± 22.0 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.050	4 months	Superiority
OG000 OG001	Chi-squared		0.003	12 months	Superiority
OG000 OG001	Chi-squared		0.049		Superiority	24 months
OG000 OG001	Chi-squared		0.097	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000484
- ParticipantsOG001480

Title	Measurements
	OG00063(38 to 83) OG00163(45 to 80)

4 Months

- ParticipantsOG000433
- ParticipantsOG001432

Title	Measurements
	OG00083(58 to 95) OG001

12 Months

- ParticipantsOG000402
- ParticipantsOG001411

Title	Measurements
	OG00084(65 to 100) OG001

24 Months

- ParticipantsOG000363
- ParticipantsOG001368

Title	Measurements
	OG00088(60 to 100) OG001

36 Months

- ParticipantsOG000321
- ParticipantsOG001324

Title	Measurements
	OG00088(69 to 100) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.40	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.13	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.86	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.89	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.87	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000604
- ParticipantsOG001590

Title	Measurements
	OG00053.3± 23.3 OG00155.5± 23.8

4 Months

- ParticipantsOG000513
- ParticipantsOG001534

Title	Measurements
	OG00058.6± 20.5 OG001

12 Months

- ParticipantsOG000470
- ParticipantsOG001470

Title	Measurements
	OG00052.8± 15.7 OG001

24 Months

- ParticipantsOG000413
- ParticipantsOG001415

Title	Measurements
	OG00051.7± 14.5 OG001

36 Months

- ParticipantsOG000411
- ParticipantsOG001390

Title	Measurements
	OG00050.7± 14.4 OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.005	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.023	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.009	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.26	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000494
- ParticipantsOG001492

Title	Measurements
	OG00050(25 to 50) OG00150(50 to 50)

4 Months

- ParticipantsOG000436
- ParticipantsOG001435

Title	Measurements
	OG00050(50 to 75) OG001

12 Months

- ParticipantsOG000408
- ParticipantsOG001416

Title	Measurements
	OG00050(50 to 50) OG001

24 Months

- ParticipantsOG000362
- ParticipantsOG001372

Title	Measurements
	OG00050(50 to 50) OG001

36 Months

- ParticipantsOG000328
- ParticipantsOG001332

Title	Measurements
	OG00050(50 to 50) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.38	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.45	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.62	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.82	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.94	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000606
- ParticipantsOG001592

Title	Measurements
	OG00070.5± 24.6 OG00171.5± 25.7

4 Months

- ParticipantsOG000519
- ParticipantsOG001534

Title	Measurements
	OG00079.8± 21.6 OG001

12 Months

- ParticipantsOG000475
- ParticipantsOG001471

Title	Measurements
	OG00082.4± 22.2 OG001

24 Months

- ParticipantsOG000415
- ParticipantsOG001417

Title	Measurements
	OG00082.2± 20.9 OG001

36 Months

- ParticipantsOG000411
- ParticipantsOG001391

Title	Measurements
	OG00081.7± 22.7 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.205	4 months	Superiority
OG000 OG001	Chi-squared		0.017	12 months	Superiority
OG000	Chi-squared		0.028	24 months	Superiority
OG000 OG001	Chi-squared		0.123	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000493
- ParticipantsOG001491

Title	Measurements
	OG00067(50 to 88) OG00171(50 to 88)

4 Months

- ParticipantsOG000440
- ParticipantsOG001434

Title	Measurements
	OG00083(63 to 100) OG001

12 Months

- ParticipantsOG000409
- ParticipantsOG001415

Title	Measurements
	OG00090(67 to 100) OG001

24 Months

- ParticipantsOG000367
- ParticipantsOG001374

Title	Measurements
	OG00092(67 to 100) OG001

36 Months

- ParticipantsOG000329
- ParticipantsOG001334

Title	Measurements
	OG00092(67 to 100) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.19	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.07	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.94	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.67	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.44	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000606
- ParticipantsOG001591

Title	Measurements
	OG00072.6± 22.5 OG00173.4± 24.4

4 Months

- ParticipantsOG000517
- ParticipantsOG001535

Title	Measurements
	OG00081.4± 20.4 OG001

12 Months

- ParticipantsOG000475
- ParticipantsOG001471

Title	Measurements
	OG00083.7± 20.6 OG001

24 Months

- ParticipantsOG000415
- ParticipantsOG001417

Title	Measurements
	OG00083.3± 20.2 OG001

36 Months

- ParticipantsOG000411
- ParticipantsOG001391

Title	Measurements
	OG00083.1± 21.2 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.050	4 months	Superiority
OG000 OG001	Chi-squared		0.006	12 months	Superiority
OG000 OG001	Chi-squared		0.039	24 months	Superiority
OG000 OG001	Chi-squared		0.074	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000494
- ParticipantsOG001492

Title	Measurements
	OG00067(50 to 92) OG00175(50 to 83)

4 Months

- ParticipantsOG000441
- ParticipantsOG001436

Title	Measurements
	OG00083(67 to 100) OG001

12 Months

- ParticipantsOG000410
- ParticipantsOG001416

Title	Measurements
	OG00092(67 to 100) OG001

24 Months

- ParticipantsOG000368
- ParticipantsOG001373

Title	Measurements
	OG00092(67 to 100) OG001

36 Months

- ParticipantsOG000329
- ParticipantsOG001332

Title	Measurements
	OG00092(67 to 100) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.23	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.43	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.35	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.90	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.48	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000606
- ParticipantsOG001592

Title	Measurements
	OG00071.7± 22.5 OG00172.6± 24.2

4 Months

- ParticipantsOG000519
- ParticipantsOG001535

Title	Measurements
	OG00080.8± 20.0 OG001

12 Months

- ParticipantsOG000475
- ParticipantsOG001471

Title	Measurements
	OG00083.2± 20.5 OG001

24 Months

- ParticipantsOG000415
- ParticipantsOG001417

Title	Measurements
	OG00082.9± 19.8 OG001

36 Months

- ParticipantsOG000411
- ParticipantsOG001391

Title	Measurements
	OG00082.5± 21.3 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.085	4 months	Superiority
OG000 OG001	Chi-squared		0.007		Superiority
OG000 OG001	Chi-squared		0.026	24 months	Superiority
OG000 OG001	Chi-squared		0.085	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000494
- ParticipantsOG001492

Title	Measurements
	OG00068(48 to 86) OG00171(52 to 88)

4 Months

- ParticipantsOG000441
- ParticipantsOG001436

Title	Measurements
	OG00084(65 to 100) OG001

12 Months

- ParticipantsOG000410
- ParticipantsOG001416

Title	Measurements
	OG00090(68 to 100) OG001

24 Months

- ParticipantsOG000368
- ParticipantsOG001374

Title	Measurements
	OG00090(71 to 100) OG001

36 Months

- ParticipantsOG000329
- ParticipantsOG001334

Title	Measurements
	OG00090(70 to 100) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.18	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.17	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.59	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.78	24 months	Superiority
OG000	Wilcoxon (Mann-Whitney)	0.48	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000606
- ParticipantsOG001591

Title	Measurements
	OG00047.9± 25.0 OG00150.1± 27.0

4 Months

- ParticipantsOG000519
- ParticipantsOG001533

Title	Measurements
	OG00068.7± 24.5 OG001

12 Months

- ParticipantsOG000472
- ParticipantsOG001469

Title	Measurements
	OG00072.9± 23.5 OG001

24 Months

- ParticipantsOG000416
- ParticipantsOG001417

Title	Measurements
	OG00071.9± 22.6 OG001

36 Months

- ParticipantsOG000410
- ParticipantsOG001390

Title	Measurements
	OG00071.2± 23.3 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	<0.001	4 months	Superiority
OG000 OG001	Chi-squared		<0.001	12 month	Superiority
OG000 OG001	Chi-squared		<0.001	24 months	Superiority
OG000 OG001	Chi-squared		0.018	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000493
- ParticipantsOG001490

Title	Measurements
	OG00042(17 to 58) OG00133(25 to 58)

4 Months

- ParticipantsOG000441
- ParticipantsOG001433

Title	Measurements
	OG00075(50 to 92) OG001

12 Months

- ParticipantsOG000409
- ParticipantsOG001416

Title	Measurements
	OG00075(50 to 92) OG001

24 Months

- ParticipantsOG000365
- ParticipantsOG001373

Title	Measurements
	OG00075(58 to 92) OG001

36 Months

- ParticipantsOG000328
- ParticipantsOG001333

Title	Measurements
	OG00075(58 to 92) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.70	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.47	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.87	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.84	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.82	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000570
- ParticipantsOG001554

Title	Measurements
	OG00056.4± 29.9 OG00157.3± 29.7

4 Months

- ParticipantsOG000495
- ParticipantsOG001510

Title	Measurements
	OG00072.3± 27.4 OG001

12 Months

- ParticipantsOG000453
- ParticipantsOG001445

Title	Measurements
	OG00076.4± 26.0 OG001

24 Months

- ParticipantsOG000395
- ParticipantsOG001402

Title	Measurements
	OG00075.4± 25.9 OG001

36 Months

- ParticipantsOG000399
- ParticipantsOG001374

Title	Measurements
	OG00075.4± 27.0 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.023	4 months	Superiority
OG000 OG001	Chi-squared		0.001	12 months	Superiority
OG000 OG001	Chi-squared		0.077	24 months	Superiority
OG000 OG001	Chi-squared		0.170	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000465
- ParticipantsOG001467

Title	Measurements
	OG00044(19 to 75) OG00144(25 to 75)

4 Months

- ParticipantsOG000424
- ParticipantsOG001412

Title	Measurements
	OG00075(50 to 94) OG001

12 Months

- ParticipantsOG000387
- ParticipantsOG001400

Title	Measurements
	OG00081(58 to 100) OG001

24 Months

- ParticipantsOG000353
- ParticipantsOG001356

Title	Measurements
	OG00081(50 to 100) OG001

36 Months

- ParticipantsOG000318
- ParticipantsOG001309

Title	Measurements
	OG00083(58 to 100) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.63	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.29	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.68	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.25	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.68	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000607
- ParticipantsOG001592

Title	Measurements
	OG00068.2± 21.8 OG00168.8± 23.1

4 Months

- ParticipantsOG000520
- ParticipantsOG001537

Title	Measurements
	OG00078.2± 20.0 OG001

12 Months

- ParticipantsOG000476
- ParticipantsOG001473

Title	Measurements
	OG00080.6± 20.3 OG001

24 Months

- ParticipantsOG000418
- ParticipantsOG001417

Title	Measurements
	OG00080.1± 19.5 OG001

36 Months

- ParticipantsOG000412
- ParticipantsOG001391

Title	Measurements
	OG00079.9± 20.2 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.033	4 months	Superiority
OG000 OG001	Chi-squared		0.002	12 months	Superiority
OG000 OG001	Chi-squared		0.015	24 months	Superiority
OG000 OG001	Chi-squared		0.051	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000496
- ParticipantsOG001492

Title	Measurements
	OG00065(46 to 83) OG00168(49 to 84)

4 Months

- ParticipantsOG000445
- ParticipantsOG001443

Title	Measurements
	OG00084(63 to 95) OG001

12 Months

- ParticipantsOG000411
- ParticipantsOG001416

Title	Measurements
	OG00088(66 to 97) OG001

24 Months

- ParticipantsOG000368
- ParticipantsOG001374

Title	Measurements
	OG00088(65 to 97) OG001

36 Months

- ParticipantsOG000329
- ParticipantsOG001335

Title	Measurements
	OG00088(67 to 98) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.26	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.23	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.66	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.98	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.86	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000607
- ParticipantsOG001592

Title	Measurements
	OG00060.3± 22.3 OG00161.3± 23.2

4 Months

- ParticipantsOG000520
- ParticipantsOG001537

Title	Measurements
	OG00074.3± 21.0 OG001

12 Months

- ParticipantsOG000476
- ParticipantsOG001473

Title	Measurements
	OG00077.5± 20.4 OG001

24 Months

- ParticipantsOG000418
- ParticipantsOG001417

Title	Measurements
	OG00076.9± 20.1 OG001

36 Months

- ParticipantsOG000412
- ParticipantsOG001391

Title	Measurements
	OG00076.6± 20.9 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	<0.001	4 months	Superiority
OG000 OG001	Chi-squared		<0.001		Superiority
OG000 OG001	Chi-squared		0.006	24 months	Superiority
OG000 OG001	Chi-squared		0.037	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000496
- ParticipantsOG001492

Title	Measurements
	OG00053(36 to 70) OG00154(38 to 72)

4 Months

- ParticipantsOG000446
- ParticipantsOG001443

Title	Measurements
	OG00079(56 to 92) OG001

12 Months

- ParticipantsOG000411
- ParticipantsOG001416

Title	Measurements
	OG00084(59 to 95) OG001

24 Months

- ParticipantsOG000368
- ParticipantsOG001374

Title	Measurements
	OG00084(60 to 95) OG001

36 Months

- ParticipantsOG000329
- ParticipantsOG001335

Title	Measurements
	OG00085(65 to 95) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.53	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.26	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.76	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.89	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.89	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000594
- ParticipantsOG001584

Title	Measurements
	OG00074.3± 26.7 OG00177.0± 26.2

4 Months

- ParticipantsOG000506
- ParticipantsOG001522

Title	Measurements
	OG00090.5± 16.9 OG001

12 Months

- ParticipantsOG000459
- ParticipantsOG001458

Title	Measurements
	OG00090.6± 16.5 OG001

24 Months

- ParticipantsOG000404
- ParticipantsOG001403

Title	Measurements
	OG00090.5± 17.2 OG001

36 Months

- ParticipantsOG000395
- ParticipantsOG001372

Title	Measurements
	OG00089.8± 17.5 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	<0.001	4 months	Superiority
OG000 OG001	Chi-squared		<0.001	12 months	Superiority
OG000 OG001	Chi-squared		<0.001	24 months	Superiority
OG000 OG001	Chi-squared		0.010	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000488
- ParticipantsOG001482

Title	Measurements
	OG00070(40 to 90) OG00180(50 to 100)

4 Months

- ParticipantsOG000414
- ParticipantsOG001412

Title	Measurements
	OG000100(90 to 100) OG001

12 Months

- ParticipantsOG000379
- ParticipantsOG001392

Title	Measurements
	OG000100(90 to 100) OG001

24 Months

- ParticipantsOG000345
- ParticipantsOG001351

Title	Measurements
	OG000100(80 to 100) OG001

36 Months

- ParticipantsOG000310
- ParticipantsOG001314

Title	Measurements
	OG000100(90 to 100) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.01	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.74	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.77	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.46	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.27	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000575
- ParticipantsOG001565

Title	Measurements
	OG00056.0± 27.1 OG00157.8± 25.0

4 Months

- ParticipantsOG000503
- ParticipantsOG001515

Title	Measurements
	OG00058.3± 20.3 OG001

12 Months

- ParticipantsOG000459
- ParticipantsOG001456

Title	Measurements
	OG00055.4± 17.3 OG001

24 Months

- ParticipantsOG000402
- ParticipantsOG001402

Title	Measurements
	OG00052.9± 14.9 OG001

36 Months

- ParticipantsOG000394
- ParticipantsOG001366

Title	Measurements
	OG00053.9± 16.9 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.029	4 months	Superiority
OG000 OG001	Chi-squared		0.042	12 months	Superiority
OG000 OG001	Chi-squared		0.30	24 months	Superiority
OG000 OG001	Chi-squared		0.20	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000477
- ParticipantsOG001462

Title	Measurements
	OG00050(25 to 50) OG00150(25 to 50)

4 Months

- ParticipantsOG000411
- ParticipantsOG001405

Title	Measurements
	OG00050(50 to 50) OG001

12 Months

- ParticipantsOG000374
- ParticipantsOG001388

Title	Measurements
	OG00050(50 to 50) OG001

24 Months

- ParticipantsOG000344
- ParticipantsOG001349

Title	Measurements
	OG00050(50 to 50) OG001

36 Months

- ParticipantsOG000310
- ParticipantsOG001313

Title	Measurements
	OG00050(50 to 50) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.98	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.16	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.88	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.95	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.48	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000585
- ParticipantsOG001574

Title	Measurements
	OG00053.6± 25.9 OG00157.6± 26.6

4 Months

- ParticipantsOG000505
- ParticipantsOG001525

Title	Measurements
	OG00074.5± 22.1 OG001

12 Months

- ParticipantsOG000457
- ParticipantsOG001457

Title	Measurements
	OG00075.8± 21.2 OG001

24 Months

- ParticipantsOG000401
- ParticipantsOG001404

Title	Measurements
	OG00075.5± 21.5 OG001

36 Months

- ParticipantsOG000395
- ParticipantsOG001371

Title	Measurements
	OG00075.3± 22.1 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	<0.001	4 months	Superiority
OG000 OG001	Chi-squared		<0.001	12 months	Superiority
OG000 OG001	Chi-squared		<0.001	24 months	Superiority
OG000 OG001	Chi-squared		0.001	36 months	Superiority

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00042(25 to 67) OG00142(25 to 67)

4 Months

Title	Measurements
	OG00083(67 to 100) OG00183(58 to 92)

12 Months

Title	Measurements
	OG00083(67 to 100) OG00183(67 to 100)

24 Months

Title	Measurements
	OG00083(58 to 100) OG00183(67 to 100)

36 Months

Title	Measurements
	OG00083(67 to 100) OG00183(67 to 100)

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.86	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.39	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.65	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.15	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.68	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000593
- ParticipantsOG001585

Title	Measurements
	OG00056.7± 19.0 OG00159.5± 18.8

4 Months

- ParticipantsOG000497
- ParticipantsOG001518

Title	Measurements
	OG00068.5± 18.1 OG001

12 Months

- ParticipantsOG000447
- ParticipantsOG001455

Title	Measurements
	OG00069.2± 17.9 OG001

24 Months

- ParticipantsOG000390
- ParticipantsOG001398

Title	Measurements
	OG00068.6± 17.8 OG001

36 Months

- ParticipantsOG000384
- ParticipantsOG001378

Title	Measurements
	OG00069.0± 17.9 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	<0.001	4 months	Superiority
OG000 OG001	Chi-squared		<0.001	12 months	Superiority
OG000 OG001	Chi-squared		0.001	24 months	Superiority
OG000 OG001	Chi-squared		0.001		Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000488
- ParticipantsOG001487

Title	Measurements
	OG00050(40 to 70) OG00150(40 to 70)

4 Months

- ParticipantsOG000420
- ParticipantsOG001415

Title	Measurements
	OG00070(60 to 80) OG001

12 Months

- ParticipantsOG000383
- ParticipantsOG001385

Title	Measurements
	OG00072(60 to 80) OG001

24 Months

- ParticipantsOG000371
- ParticipantsOG001352

Title	Measurements
	OG00070(50 to 80) OG001

36 Months

- ParticipantsOG000330
- ParticipantsOG001331

Title	Measurements
	OG00070(50 to 80) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.96	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.53	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.37	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.78	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.21	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000584
- ParticipantsOG001570

Title	Measurements
	OG00069.3± 25.8 OG00172.3± 24.4

4 Months

- ParticipantsOG000489
- ParticipantsOG001504

Title	Measurements
	OG00078.9± 24.5 OG001

12 Months

- ParticipantsOG000439
- ParticipantsOG001453

Title	Measurements
	OG00080.5± 22.3 OG001

24 Months

- ParticipantsOG000386
- ParticipantsOG001394

Title	Measurements
	OG00079.6± 24.6 OG001

36 Months

- ParticipantsOG000379
- ParticipantsOG001371

Title	Measurements
	OG00081.4± 23.4 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.007	4 months	Superiority
OG000 OG001	Chi-squared		0.003	12 months	Superiority
OG000 OG001	Chi-squared		0.023	24 months	Superiority
OG000 OG001	Chi-squared		0.060	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000475
- ParticipantsOG001477

Title	Measurements
	OG00069(52 to 81) OG00169(59 to 81)

4 Months

- ParticipantsOG000405
- ParticipantsOG001395

Title	Measurements
	OG00085(69 to 100) OG001

12 Months

- ParticipantsOG000375
- ParticipantsOG001379

Title	Measurements
	OG00085(73 to 100) OG001

24 Months

- ParticipantsOG000356
- ParticipantsOG001339

Title	Measurements
	OG00085(69 to 100) OG001

36 Months

- ParticipantsOG000323
- ParticipantsOG001322

Title	Measurements
	OG00085(69 to 100) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.31	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.43	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.57	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.95	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.38	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000595
- ParticipantsOG001583

Title	Measurements
	OG00042.9 OG00143.4

4 Months

- ParticipantsOG000501
- ParticipantsOG001521

Title	Measurements
	OG00026.6 OG001

12 Months

- ParticipantsOG000457
- ParticipantsOG001454

Title	Measurements
	OG00025.0 OG001

24 Months

- ParticipantsOG000399
- ParticipantsOG001402

Title	Measurements
	OG00024.1 OG001

36 Months

- ParticipantsOG000393
- ParticipantsOG001370

Title	Measurements
	OG00022.4 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	All P-values were based on the Likelihood Ratio Chi-Square test.	0.86	Baseline	Superiority
OG000 OG001	Chi-squared	All P-values were based on the Likelihood Ratio Chi-Square test.	0.78	4 months	Superiority
OG000 OG001	Chi-squared	All P-values were based on the Likelihood Ratio Chi-Square test.	0.55	12 months	Superiority
OG000 OG001	Chi-squared	All P-values were based on the Likelihood Ratio Chi-Square test.	0.027	24 months	Superiority
OG000 OG001	Chi-squared	All P-values were based on the Likelihood Ratio Chi-Square test.	0.031	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000496
- ParticipantsOG001495

Title	Measurements
	OG00050.5 OG00153.2

4 Months

- ParticipantsOG000449
- ParticipantsOG001448

Title	Measurements
	OG00029.6 OG001

12 Months

- ParticipantsOG000411
- ParticipantsOG001417

Title	Measurements
	OG00024.4 OG001

24 Months

- ParticipantsOG000371
- ParticipantsOG001379

Title	Measurements
	OG00028.1 OG001

36 Months

- ParticipantsOG000333
- ParticipantsOG001336

Title	Measurements
	OG00020.8 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	All P-values were based on the Likelihood Ratio Chi-Square test.	0.40	Baseline	Superiority
OG000 OG001	Chi-squared	All P-values were based on the Likelihood Ratio Chi-Square test.	0.42	4 months	Superiority
OG000 OG001	Chi-squared	All P-values were based on the Likelihood Ratio Chi-Square test.	0.41	12 months	Superiority
OG000 OG001	Chi-squared	All P-values were based on the Likelihood Ratio Chi-Square test.	0.25	24 months	Superiority
OG000 OG001	Chi-squared	All P-values were based on the Likelihood Ratio Chi-Square test.	0.25	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000596
- ParticipantsOG001581

Title	Measurements
	OG00046.8± 24.3 OG00149.3± 24.9

4 Months

- ParticipantsOG000504
- ParticipantsOG001521

Title	Measurements
	OG00056.0± 25.0 OG001

12 Months

- ParticipantsOG000455
- ParticipantsOG001456

Title	Measurements
	OG00056.7± 25.9 OG001

24 Months

- ParticipantsOG000399
- ParticipantsOG001401

Title	Measurements
	OG00055.3± 25.2 OG001

36 Months

- ParticipantsOG000392
- ParticipantsOG001370

Title	Measurements
	OG00056.2± 26.0 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.002	4 months	Superiority
OG000 OG001	Chi-squared		0.007	12 months	Superiority
OG000 OG001	Chi-squared		0.049	24 months	Superiority
OG000 OG001	Chi-squared		0.038	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000487
- ParticipantsOG001481

Title	Measurements
	OG00045(25 to 63) OG00145(25 to 67)

4 Months

- ParticipantsOG000406
- ParticipantsOG001409

Title	Measurements
	OG00061(38 to 75) OG001

12 Months

- ParticipantsOG000381
- ParticipantsOG001386

Title	Measurements
	OG00065(42 to 80) OG001

24 Months

- ParticipantsOG000344
- ParticipantsOG001347

Title	Measurements
	OG00063(44 to 78) OG001

36 Months

- ParticipantsOG000306
- ParticipantsOG001307

Title	Measurements
	OG00058(40 to 75) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.40	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.37	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.98	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.15	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.04	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000599
- ParticipantsOG001583

Title	Measurements
	OG00062.9± 22.5 OG00164.8± 21.2

4 Months

- ParticipantsOG000504
- ParticipantsOG001522

Title	Measurements
	OG00069.2± 20.6 OG001

12 Months

- ParticipantsOG000454
- ParticipantsOG001458

Title	Measurements
	OG00068.7± 20.3 OG001

24 Months

- ParticipantsOG000401
- ParticipantsOG001403

Title	Measurements
	OG00068.3± 20.4 OG001

36 Months

- ParticipantsOG000393
- ParticipantsOG001370

Title	Measurements
	OG00069.7± 21.0 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.036	4 months	Superiority
OG000 OG001	Chi-squared		0.043	12 months	Superiority
OG000 OG001	Chi-squared		0.018	24 months	Superiority
OG000 OG001	Chi-squared		0.037	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000487
- ParticipantsOG001482

Title	Measurements
	OG00063(47 to 75) OG00163(47 to 75)

4 Months

- ParticipantsOG000412
- ParticipantsOG001409

Title	Measurements
	OG00075(62 to 91) OG001

12 Months

- ParticipantsOG000381
- ParticipantsOG001387

Title	Measurements
	OG00075(63 to 91) OG001

24 Months

- ParticipantsOG000346
- ParticipantsOG001347

Title	Measurements
	OG00075(63 to 92) OG001

36 Months

- ParticipantsOG000311
- ParticipantsOG001314

Title	Measurements
	OG00075(63 to 84) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.75	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.72	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.77	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.52	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.12	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000579
- ParticipantsOG001554

Title	Measurements
	OG00056.0± 19.4 OG00157.6± 19.0

4 Months

- ParticipantsOG000486
- ParticipantsOG001493

Title	Measurements
	OG00067.3± 19.1 OG001

12 Months

- ParticipantsOG000438
- ParticipantsOG001437

Title	Measurements
	OG00068.7± 18.7 OG001

24 Months

- ParticipantsOG000388
- ParticipantsOG001391

Title	Measurements
	OG00068.1± 19.2 OG001

36 Months

- ParticipantsOG000385
- ParticipantsOG001364

Title	Measurements
	OG00069.1± 31.6 OG001

Group IDs	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Chi-squared	H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.	0.0002	4 months	Superiority
OG000 OG001	Chi-squared		<0.0001	12 months	Superiority
OG000 OG001	Chi-squared		0.009	24 months	Superiority
OG000 OG001	Chi-squared		0.32	36 months	Superiority

Title

Denominators

Categories

Baseline

- ParticipantsOG000466
- ParticipantsOG001458

Title	Measurements
	OG00050(40 to 70) OG00150(40 to 70)

4 Months

- ParticipantsOG000387
- ParticipantsOG001389

Title	Measurements
	OG00070(50 to 80) OG001

12 Months

- ParticipantsOG000367
- ParticipantsOG001370

Title	Measurements
	OG00070(50 to 80) OG001

24 Months

- ParticipantsOG000338
- ParticipantsOG001339

Title	Measurements
	OG00070(50 to 80) OG001

36 Months

- ParticipantsOG000298
- ParticipantsOG001303

Title	Measurements
	OG00070(60 to 80) OG001

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.60	Baseline	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.14	4 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.57	12 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.15	24 months	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.84	36 months	Superiority

Title

Denominators

Categories

Hospital Costs

Title	Measurements
	OG00050,032± 41,622 OG0018,315± 19,719

Physician Fees

Title	Measurements
	OG0005,405± 2,377 OG001408± 819

Total Index Cost

Title	Measurements
	OG00055,437± 43,460 OG0018,723± 20,506

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	<0.0001	Hospital costs	Superiority
OG000	Wilcoxon (Mann-Whitney)	<0.0001	Physician fees	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	<0.0001	Total index cost	Superiority

Title

Denominators

Categories

Hospital Costs

Title	Measurements
	OG00050,939± 46,458 OG00164,202± 49,172

Physician Fees

Title	Measurements
	OG0005,183± 2,306 OG0016,515± 2,463

Total Index Cost

Title	Measurements
	OG00056,122± 48,552 OG00170,717± 51,367

Group IDs	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Wilcoxon (Mann-Whitney)	0.006	Hospital costs	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	<0.0001	Physician fees	Superiority
OG000 OG001	Wilcoxon (Mann-Whitney)	0.004	Total index cost	Superiority

ID	Term
D002318	Cardiovascular Diseases
D003327	Coronary Disease
D006333	Heart Failure
D006331	Heart Diseases

ID	Term
D017202	Myocardial Ischemia
D014652	Vascular Diseases