Trial Outcomes & Findings for Modified Application of Cardiac Rehabilitation for Older Adults (NCT NCT03922529)

NCT ID: NCT03922529

Last Updated: 2025-09-22

Results Overview

AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 416 participants
• Primary outcome timeframe: 3 months, i.e., Baseline to 3-month change
• Results posted on: 2025-09-22

Participant Flow

The original recruitment target was 480 beginning in November 2019. Due to the COVID-19 pandemic, the DSMB recommended suspension and withdrawal of all enrolled subjects in March 2020. The protocol was revised to be fully remote, and recruitment was reinitiated with a smaller target sample in September 2020. Enrollment ended in August 2023. 416 subjects consented to the study (total enrolled), and 350 completed the required baseline assessments to be randomized to an intervention group.

After informed consent, subjects completed a set of baseline questionnaires. Participants who did not meet the score requirements on the Short Blessed cognitive assessment at baseline were disqualified before randomization. Other reasons for withdrawal prior to randomization assignment included subject-initiated withdrawal, adverse event, death, or loss to follow-up after discharge from inpatient hospital admission. Participants must have completed baseline assessments in order to be randomized.

Participant milestones

Measure	MACRO-I A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.	Usual Care Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.
Overall Study STARTED	176	174
Overall Study COMPLETED	140	131
Overall Study NOT COMPLETED	36	43

Reasons for withdrawal

Measure	MACRO-I A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.	Usual Care Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.
Overall Study Withdrawal by Subject	13	12
Overall Study Death	7	12
Overall Study Lost to Follow-up	12	19
Overall Study Adverse Event	1	0
Overall Study Death after withdrawal	1	0
Overall Study Participant was contacted for final visit and declined to complete	1	0
Overall Study Moved to assisted living and was unreachable for follow-up assessments	1	0

Baseline Characteristics

Modified Application of Cardiac Rehabilitation for Older Adults

Baseline characteristics by cohort

Measure	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	Total n=350 Participants Total of all reporting groups
Age, Continuous	75.9 years STANDARD_DEVIATION 4.9 • n=5 Participants	76.4 years STANDARD_DEVIATION 5.7 • n=7 Participants	76.1 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	58 Participants n=7 Participants	108 Participants n=5 Participants
Sex: Female, Male Male	126 Participants n=5 Participants	116 Participants n=7 Participants	242 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	173 Participants n=5 Participants	171 Participants n=7 Participants	344 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) White	155 Participants n=5 Participants	152 Participants n=7 Participants	307 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	176 participants n=5 Participants	174 participants n=7 Participants	350 participants n=5 Participants
Marital Status Married or permanent partnership	95 Participants n=5 Participants	102 Participants n=7 Participants	197 Participants n=5 Participants
Marital Status Widowed	42 Participants n=5 Participants	37 Participants n=7 Participants	79 Participants n=5 Participants
Marital Status Divorced or separated	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Marital Status Never married	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Marital Status In a relationship	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Marital Status Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Social Support Lives alone	69 Participants n=5 Participants	50 Participants n=7 Participants	119 Participants n=5 Participants
Social Support Lives with others	107 Participants n=5 Participants	124 Participants n=7 Participants	231 Participants n=5 Participants
AM-PAC CAT Basic Mobility	57.3 score on a scale STANDARD_DEVIATION 6.5 • n=5 Participants	56.3 score on a scale STANDARD_DEVIATION 7.4 • n=7 Participants	56.8 score on a scale STANDARD_DEVIATION 7.0 • n=5 Participants
AM-PAC CAT Daily Activity	54.6 score on a scale STANDARD_DEVIATION 8.6 • n=5 Participants	55.2 score on a scale STANDARD_DEVIATION 9.1 • n=7 Participants	54.9 score on a scale STANDARD_DEVIATION 8.8 • n=5 Participants
Average total active time/24 hours (minutes)	324.1 minutes/24 hours STANDARD_DEVIATION 127.4 • n=5 Participants	347.8 minutes/24 hours STANDARD_DEVIATION 130.0 • n=7 Participants	335.0 minutes/24 hours STANDARD_DEVIATION 128.8 • n=5 Participants
Patient Health Questionnaire-9	4.7 score on a scale STANDARD_DEVIATION 3.1 • n=5 Participants	4.9 score on a scale STANDARD_DEVIATION 2.8 • n=7 Participants	4.8 score on a scale STANDARD_DEVIATION 3.0 • n=5 Participants
Morley Frail Scale	2.3 score on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	2.2 score on a scale STANDARD_DEVIATION 1.4 • n=7 Participants	2.2 score on a scale STANDARD_DEVIATION 1.4 • n=5 Participants
Sullivan Cardiac Self Efficacy	34.8 score on a scale STANDARD_DEVIATION 7.6 • n=5 Participants	35.0 score on a scale STANDARD_DEVIATION 7.2 • n=7 Participants	34.9 score on a scale STANDARD_DEVIATION 7.4 • n=5 Participants
Veterans RAND-12 Physical Summary Score	28.6 score on a scale STANDARD_DEVIATION 10.1 • n=5 Participants	28.5 score on a scale STANDARD_DEVIATION 10.4 • n=7 Participants	28.5 score on a scale STANDARD_DEVIATION 10.3 • n=5 Participants
Veterans RAND-12 Mental Summary Score	50.0 score on a scale STANDARD_DEVIATION 10.0 • n=5 Participants	49.8 score on a scale STANDARD_DEVIATION 8.9 • n=7 Participants	49.9 score on a scale STANDARD_DEVIATION 9.5 • n=5 Participants
Modified Rapid Eating Assessment for Participants-Shortened Version	31.1 score on a scale STANDARD_DEVIATION 3.9 • n=5 Participants	31.4 score on a scale STANDARD_DEVIATION 4.3 • n=7 Participants	31.2 score on a scale STANDARD_DEVIATION 4.1 • n=5 Participants
Duke Activity Status Index	25.3 score on a scale STANDARD_DEVIATION 15.7 • n=5 Participants	25.6 score on a scale STANDARD_DEVIATION 16.5 • n=7 Participants	25.4 score on a scale STANDARD_DEVIATION 16.1 • n=5 Participants
Fall History	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months, i.e., Baseline to 3-month change

Population: All 350 randomized participants were analyzed with multiple imputation (Markov Chain Monte Carlo or MCMC method) for any missing or incomplete outcomes data.

AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
AM-PAC-CAT - Basic Mobility Domain	5.0 score on a scale Standard Deviation 5.4	5.1 score on a scale Standard Deviation 7.5

SECONDARY outcome

Timeframe: Baseline to 6-month change

AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
AM-PAC-CAT - Basic Mobility Domain	5.2 score on a scale Standard Deviation 5.9	4.9 score on a scale Standard Deviation 6.7

SECONDARY outcome

Timeframe: Baseline to 12-month change

AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
AM-PAC-CAT - Basic Mobility Domain	5.3 score on a scale Standard Deviation 6.5	4.9 score on a scale Standard Deviation 7.3

SECONDARY outcome

Timeframe: Baseline to 3-month change

AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
AM-PAC-CAT - Daily Activity Domain	4.5 score on a scale Standard Deviation 11.1	5.8 score on a scale Standard Deviation 8.8

SECONDARY outcome

Timeframe: Baseline to 6-month change

AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
AM-PAC-CAT - Daily Activity Domain	5.2 score on a scale Standard Deviation 10.6	6.3 score on a scale Standard Deviation 10.0

SECONDARY outcome

Timeframe: Baseline to 12-month change

AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
AM-PAC-CAT - Daily Activity Domain	5.1 score on a scale Standard Deviation 11.3	6.9 score on a scale Standard Deviation 11.2

SECONDARY outcome

Timeframe: Baseline to 3-month change

Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Accelerometry	13.9 minutes/24 hours Standard Deviation 115.4	37.3 minutes/24 hours Standard Deviation 95.8

SECONDARY outcome

Timeframe: Baseline to 6-month change

Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Accelerometry	18.3 minutes/24 hours Standard Deviation 127.4	34.0 minutes/24 hours Standard Deviation 100.8

SECONDARY outcome

Timeframe: Baseline to 12-month change

Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Accelerometry	12.9 minutes/24 hours Standard Deviation 119.1	44.8 minutes/24 hours Standard Deviation 121.6

SECONDARY outcome

Timeframe: Baseline to 3-month change

The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)	-2.2 score on a scale Standard Deviation 2.9	-2.1 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline to 6-month change

The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)	-2.2 score on a scale Standard Deviation 2.8	-1.9 score on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: Baseline to 12-month change

The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)	-2.3 score on a scale Standard Deviation 3.0	-1.7 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: Baseline to 3-month change

The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Morley Frail Scale	-0.4 score on a scale Standard Deviation 1.3	-0.5 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline to 6-month change

The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Morley Frail Scale	-0.5 score on a scale Standard Deviation 1.4	-0.4 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline to 12-month change

The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Morley Frail Scale	-0.4 score on a scale Standard Deviation 1.5	-0.6 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline to 3-month change

The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Sullivan Cardiac Self-Efficacy	3.0 score on a scale Standard Deviation 7.9	3.2 score on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: Baseline to 6-month change

The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Sullivan Cardiac Self-Efficacy	1.8 score on a scale Standard Deviation 8.7	2.9 score on a scale Standard Deviation 8.9

SECONDARY outcome

Timeframe: Baseline to 12-month change

The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Sullivan Cardiac Self-Efficacy	1.3 score on a scale Standard Deviation 8.7	2.7 score on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: Baseline to 3-month change

The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score	5.6 score on a scale Standard Deviation 11.8	7.4 score on a scale Standard Deviation 10.4

SECONDARY outcome

Timeframe: Baseline to 6-month change

The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score	7.0 score on a scale Standard Deviation 11.1	7.1 score on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: Baseline to 12-month change

The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score	5.1 score on a scale Standard Deviation 13.5	7.4 score on a scale Standard Deviation 11.6

SECONDARY outcome

Timeframe: Baseline to 3-month change

RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score	5.5 score on a scale Standard Deviation 9.2	4.6 score on a scale Standard Deviation 9.5

SECONDARY outcome

Timeframe: Baseline to 6-month change

RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score	5.5 score on a scale Standard Deviation 9.2	4.6 score on a scale Standard Deviation 9.5

SECONDARY outcome

Timeframe: Baseline to 12-month change

RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score	6.4 score on a scale Standard Deviation 8.2	4.6 score on a scale Standard Deviation 10.4

SECONDARY outcome

Timeframe: 3 months

Participants will be asked about participation and adherence in cardiac rehabilitation as well as participants' medical records to evaluate utilization of cardiac rehab. Participation is measured as the number of sessions attended which ranges from 0 to 36. It is assumed that more sessions attended is better.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Cardiac Rehabilitation Participation	10.6 number of sessions attended Standard Deviation 12.6	10.1 number of sessions attended Standard Deviation 12.0

SECONDARY outcome

Timeframe: 12 months

Participants will be asked about hospitalizations during blinded monthly calls and follow-up assessments. Participants' medical records may also be reviewed to evaluate readmission to the hospital. Rate of hospitalizations per person year will be reported by group. It is assumed that a lower number of hospitalizations is better.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Hospitalizations	0.60 events per person year	0.69 events per person year

SECONDARY outcome

Timeframe: Baseline to 3-month Change

The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Duke Activity Status Index (DASI)	7.1 score on a scale Standard Deviation 14.2	10.1 score on a scale Standard Deviation 15.4

SECONDARY outcome

Timeframe: Baseline to 6-month Change

The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Duke Activity Status Index (DASI)	7.7 score on a scale Standard Deviation 13.7	8.5 score on a scale Standard Deviation 15.9

SECONDARY outcome

Timeframe: Baseline to 12-month Change

The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Duke Activity Status Index (DASI)	8.0 score on a scale Standard Deviation 15.9	9.1 score on a scale Standard Deviation 15.6

SECONDARY outcome

Timeframe: Baseline to 3-month Change

The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns.

A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Rapid Eating Assessment for Participants (Modified REAP-S)	2.7 score on a scale Standard Deviation 3.9	2.8 score on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: Baseline to 6-month Change

The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns.

A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Rapid Eating Assessment for Participants (Modified REAP-S)	2.9 score on a scale Standard Deviation 3.8	3.1 score on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: Baseline to 12-month Change

The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns.

A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Rapid Eating Assessment for Participants (Modified REAP-S)	3.0 score on a scale Standard Deviation 3.8	3.1 score on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: Baseline

Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint. An increased readiness for change is associated with greater likelihood of goal attainment.

Outcome measures

Measure	Usual Care n=174 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=176 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Readiness for Change Precontemplation	5 Participants	4 Participants
Readiness for Change Contemplation	43 Participants	40 Participants
Readiness for Change Preparation	55 Participants	60 Participants
Readiness for Change Action	70 Participants	65 Participants
Readiness for Change Maintenance	1 Participants	7 Participants

SECONDARY outcome

Timeframe: 3 Months

Population: 153 participants in the MACRO-I arm and 150 in the Usual Care arm completed the Readiness for Change at the 3 month time point.

Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint.

Outcome measures

Measure	Usual Care n=150 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=153 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Readiness for Change Precontemplation	3 Participants	2 Participants
Readiness for Change Contemplation	8 Participants	8 Participants
Readiness for Change Preparation	14 Participants	9 Participants
Readiness for Change Action	88 Participants	102 Participants
Readiness for Change Maintenance	37 Participants	32 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: 144 participants in the MACRO-I arm and 137 in the Usual Care arm completed the Readiness for Change at the 6 month assessment.

Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint.

Outcome measures

Measure	Usual Care n=137 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=144 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Readiness for Change Precontemplation	2 Participants	5 Participants
Readiness for Change Contemplation	6 Participants	5 Participants
Readiness for Change Preparation	18 Participants	9 Participants
Readiness for Change Action	55 Participants	51 Participants
Readiness for Change Maintenance	56 Participants	74 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: 137 participants in the MACRO-I arm and 129 in the Usual Care arm completed the Readiness for Change at the 12 month assessment.

Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint.

Outcome measures

Measure	Usual Care n=129 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=137 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Readiness for Change Precontemplation	2 Participants	8 Participants
Readiness for Change Contemplation	9 Participants	4 Participants
Readiness for Change Preparation	12 Participants	10 Participants
Readiness for Change Action	40 Participants	34 Participants
Readiness for Change Maintenance	66 Participants	81 Participants

SECONDARY outcome

Timeframe: 12 months

Population: 158 participants in the MACRO-i arm and 153 in Usual Care completed the fall assessment at follow-up.

Falls are a common, deleterious, and expensive aspect of aging which may be preventable via the tenets of MACRO such as good transitional care, age-appropriate exercise, and de-prescribing. We will measure falls as follows: at baseline, we will ask, "Have you had any falls in the past 3 months?" In follow-up assessments, we will ask about interim falls, as well as their severity (e.g., if they caused injury).

For the outcome assessment, the count of participants in each group who reported having at least one fall over the 12 month period following randomization is reported.

Outcome measures

Measure	Usual Care n=153 Participants Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.	MACRO-I n=158 Participants A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
Fall Assessment	50 Participants	52 Participants

Adverse Events

MACRO-I

Serious events: 74 serious events

Other events: 103 other events

Deaths: 8 deaths

Usual Care

Serious events: 70 serious events

Other events: 93 other events

Deaths: 12 deaths

Serious adverse events

Measure	MACRO-I n=176 participants at risk A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.	Usual Care n=174 participants at risk Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.
Nervous system disorders PARESTHESIA	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Nervous system disorders STROKE	1.7% 3/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.7% 3/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Nervous system disorders SYNCOPE	2.3% 4/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Nervous system disorders INTRACRANIAL HEMORRHAGE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Nervous system disorders ISCHEMIA CEREBROVASCULAR	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY	1.7% 3/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Nervous system disorders ENCEPHALOPATHY	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Blood and lymphatic system disorders ANEMIA	1.7% 3/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders AORTIC VALVE DISEASE	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders ATRIAL FIBRILLATION	1.7% 3/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	2.3% 4/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders ATRIAL FLUTTER	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders CARDIAC ARREST	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	2.3% 4/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders CARDIAC DISORDERS - OTHER, SPECIFY	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders CHEST PAIN - CARDIAC	4.5% 8/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	2.3% 4/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders HEART FAILURE	5.7% 10/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	4.6% 8/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders MITRAL VALVE DISEASE	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders MYOCARDIAL INFARCTION	2.8% 5/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders RESTRICTIVE CARDIOMYOPATHY	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders SINUS BRADYCARDIA	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders SINUS TACHYCARDIA	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders VENTRICULAR TACHYCARDIA	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Ear and labyrinth disorders VERTIGO	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders CONSTIPATION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders DIARRHEA	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders DUODENAL HEMORRHAGE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders GASTROINTESTINAL PAIN	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders LOWER GASTROINTESTINAL HEMORRHAGE	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders PANCREATITIS	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders RECTAL HEMORRHAGE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders UPPER GASTROINTESTINAL HEMORRHAGE	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders VOMITING	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
General disorders DEATH NOS	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
General disorders EDEMA LIMBS	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
General disorders FLU LIKE SYMPTOMS	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
General disorders MULTI-ORGAN FAILURE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
General disorders NON-CARDIAC CHEST PAIN	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
General disorders PAIN	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
General disorders SUDDEN DEATH NOS	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Hepatobiliary disorders CHOLECYSTITIS	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Hepatobiliary disorders HEPATOBILIARY DISORDERS - OTHER, SPECIFY	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations ENDOCARDITIS INFECTIVE	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	3.4% 6/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations JOINT INFECTION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations LUNG INFECTION	2.3% 4/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations SEPSIS	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations UPPER RESPIRATORY INFECTION	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations URINARY TRACT INFECTION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations WOUND INFECTION	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications FALL	2.8% 5/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	2.9% 5/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications FRACTURE	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications HIP FRACTURE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPEC	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications SPINAL FRACTURE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications VASCULAR ACCESS COMPLICATION	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Investigations CARDIAC TROPONIN T INCREASED	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Metabolism and nutrition disorders HYPERGLYCEMIA	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Metabolism and nutrition disorders HYPOGLYCEMIA	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Musculoskeletal and connective tissue disorders ARTHRITIS	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Musculoskeletal and connective tissue disorders BUTTOCK PAIN	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Musculoskeletal and connective tissue disorders CHEST WALL PAIN	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Musculoskeletal and connective tissue disorders SOFT TISSUE NECROSIS LOWER LIMB	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Nervous system disorders TRANSIENT ISCHEMIC ATTACKS	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Psychiatric disorders HALLUCINATIONS	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Psychiatric disorders SUICIDAL IDEATION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Renal and urinary disorders CHRONIC KIDNEY DISEASE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Reproductive system and breast disorders VAGINAL HEMORRHAGE	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders ASPIRATION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders DYSPNEA	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	2.9% 5/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders PULMONARY EDEMA	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	2.9% 5/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Surgical and medical procedures SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY	3.4% 6/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	5.7% 10/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Vascular disorders HEMATOMA	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Vascular disorders HYPERTENSION	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Vascular disorders HYPOTENSION	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Vascular disorders LYMPHEDEMA	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Vascular disorders PERIPHERAL ISCHEMIA	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Vascular disorders VASCULAR DISORDERS - OTHER, SPECIFY	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".

Other adverse events

Measure	MACRO-I n=176 participants at risk A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.	Usual Care n=174 participants at risk Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.
Blood and lymphatic system disorders ANEMIA	1.7% 3/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders AORTIC VALVE DISEASE	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders ATRIAL FIBRILLATION	2.3% 4/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	2.3% 4/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders CARDIAC DISORDERS - OTHER, SPECIFY	1.7% 3/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders CHEST PAIN - CARDIAC	3.4% 6/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	4.0% 7/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders LEFT VENTRICULAR SYSTOLIC DYSFUNCTION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders MITRAL VALVE DISEASE	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders SICK SINUS SYNDROME	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders SINUS BRADYCARDIA	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders VENTRICULAR ARRHYTHMIA	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Cardiac disorders VENTRICULAR TACHYCARDIA	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Ear and labyrinth disorders EAR PAIN	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Ear and labyrinth disorders MIDDLE EAR INFLAMMATION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Ear and labyrinth disorders VERTIGO	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Endocrine disorders HYPERTHYROIDISM	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Eye disorders BLURRED VISION	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Eye disorders CATARACT	2.8% 5/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders ABDOMINAL DISTENSION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders ABDOMINAL PAIN	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders COLITIS	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders CONSTIPATION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders DENTAL CARIES	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders DIARRHEA	2.8% 5/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders ESOPHAGEAL OBSTRUCTION	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders GASTRIC ULCER	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders GASTRITIS	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders GASTROINTESTINAL PAIN	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.7% 3/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders HEMORRHOIDS	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders NAUSEA	1.7% 3/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Gastrointestinal disorders ORAL HEMORRHAGE	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
General disorders EDEMA LIMBS	2.8% 5/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	4.0% 7/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
General disorders FATIGUE	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
General disorders FLU LIKE SYMPTOMS	4.5% 8/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.7% 3/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
General disorders PAIN	1.7% 3/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	6.3% 11/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations BRONCHIAL INFECTION	1.7% 3/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations CONJUNCTIVITIS	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	14.2% 25/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	16.1% 28/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations JOINT INFECTION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations KIDNEY INFECTION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations LUNG INFECTION	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations PHARYNGITIS	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations RASH PUSTULAR	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations RHINITIS INFECTIVE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations SHINGLES	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations SINUSITIS	1.7% 3/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations TOOTH INFECTION	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations UPPER RESPIRATORY INFECTION	2.8% 5/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	4.6% 8/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Infections and infestations URINARY TRACT INFECTION	3.4% 6/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications BRUISING	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications BURN	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications FALL	13.6% 24/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	11.5% 20/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications FRACTURE	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications INJURY TO CAROTID ARTERY	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications SPINAL FRACTURE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications VACCINATION COMPLICATION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications VASCULAR ACCESS COMPLICATION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Injury, poisoning and procedural complications WRIST FRACTURE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Investigations INVESTIGATIONS - OTHER, SPECIFY	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Metabolism and nutrition disorders HYPERKALEMIA	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Metabolism and nutrition disorders HYPOGLYCEMIA	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Metabolism and nutrition disorders HYPOKALEMIA	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Musculoskeletal and connective tissue disorders ARTHRITIS	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	2.3% 4/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Musculoskeletal and connective tissue disorders BACK PAIN	1.7% 3/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	3.4% 6/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Musculoskeletal and connective tissue disorders BUTTOCK PAIN	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Musculoskeletal and connective tissue disorders FLANK PAIN	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Musculoskeletal and connective tissue disorders MUSCLE CRAMP	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY	1.7% 3/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	4.0% 7/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN PAPILLOMA	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Nervous system disorders DIZZINESS	1.7% 3/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Nervous system disorders HEADACHE	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Nervous system disorders MUSCLE WEAKNESS LEFT-SIDED	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Nervous system disorders PARESTHESIA	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Nervous system disorders PRESYNCOPE	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Nervous system disorders SYNCOPE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.7% 3/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Nervous system disorders TRANSIENT ISCHEMIC ATTACKS	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Psychiatric disorders CONFUSION	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Psychiatric disorders DEPRESSION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Renal and urinary disorders HEMATURIA	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Renal and urinary disorders RENAL CALCULI	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Renal and urinary disorders URINARY URGENCY	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Reproductive system and breast disorders PROSTATIC OBSTRUCTION	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders COUGH	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders DYSPNEA	2.3% 4/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	4.6% 8/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders HYPOXIA	1.7% 3/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPE	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders RHINORRHEA	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Respiratory, thoracic and mediastinal disorders WHEEZING	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Skin and subcutaneous tissue disorders ECZEMA	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Skin and subcutaneous tissue disorders RASH ACNEIFORM	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.7% 3/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Surgical and medical procedures SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY	4.5% 8/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	4.6% 8/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Vascular disorders HEMATOMA	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.1% 2/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Vascular disorders HYPERTENSION	1.1% 2/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	4.6% 8/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Vascular disorders HYPOTENSION	2.8% 5/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	1.7% 3/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Vascular disorders PERIPHERAL ISCHEMIA	0.00% 0/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.57% 1/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
Vascular disorders THROMBOEMBOLIC EVENT	0.57% 1/176 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".	0.00% 0/174 • Adverse event data were collected for all randomized participants over a 1 year follow-up period. For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".

Additional Information

Daniel Forman, MD

University of Pittsburgh

Phone: 412-360-2411

Email: formand@pitt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place