Trial Outcomes & Findings for Strategies to Reduce Injuries and Develop Confidence in Elders (NCT NCT02475850)

Last Updated: 2021-03-03

Results Overview

Number of first adjudicated serious fall-related injury serious fall-related injury events per 100 per years of follow-up.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

5451 participants

Primary outcome timeframe

Enrollment through last completed follow-up or death interview (max 44 months)

Results posted on

2021-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention - Fall Prevention Standard of Care An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach Evidence-based tailored fall prevention	Control Usual fall prevention care Usual care
Overall Study STARTED	2802	2649
Overall Study COMPLETED	2209	2165
Overall Study NOT COMPLETED	593	484

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention - Fall Prevention Standard of Care An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach Evidence-based tailored fall prevention	Control Usual fall prevention care Usual care
Overall Study Death	155	141
Overall Study Lost to Follow-up	217	188
Overall Study Withdrawal by Subject	221	155

Baseline Characteristics

Strategies to Reduce Injuries and Develop Confidence in Elders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=2649 Participants Usual fall prevention care Usual care	Intervention n=2802 Participants An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach Evidence-based tailored fall prevention	Total n=5451 Participants Total of all reporting groups
Age, Continuous	79.5 Years STANDARD_DEVIATION 5.8 • n=5 Participants	79.9 Years STANDARD_DEVIATION 5.7 • n=7 Participants	79.7 Years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	1629 Participants n=5 Participants	1752 Participants n=7 Participants	3381 Participants n=5 Participants
Sex: Female, Male Male	1020 Participants n=5 Participants	1050 Participants n=7 Participants	2070 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	211 Participants n=5 Participants	196 Participants n=7 Participants	407 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2428 Participants n=5 Participants	2592 Participants n=7 Participants	5020 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Asian	26 Participants n=5 Participants	44 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Black or African American	164 Participants n=5 Participants	128 Participants n=7 Participants	292 Participants n=5 Participants
Race (NIH/OMB) White	2394 Participants n=5 Participants	2571 Participants n=7 Participants	4965 Participants n=5 Participants
Race (NIH/OMB) More than one race	22 Participants n=5 Participants	16 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	38 Participants n=5 Participants	34 Participants n=7 Participants	72 Participants n=5 Participants
Positive on Fall Risk Screening Questions Fallen 2 or more times in past year	896 Participants n=5 Participants	1015 Participants n=7 Participants	1911 Participants n=5 Participants
Positive on Fall Risk Screening Questions Fallen and hurt yourself in past year	1031 Participants n=5 Participants	1089 Participants n=7 Participants	2120 Participants n=5 Participants
Positive on Fall Risk Screening Questions Fear of falling because of balance or walking problems	2274 Participants n=5 Participants	2405 Participants n=7 Participants	4679 Participants n=5 Participants
Educational Level High school graduate or less	643 Participants n=5 Participants	602 Participants n=7 Participants	1245 Participants n=5 Participants
Educational Level Some college or equivalent	659 Participants n=5 Participants	697 Participants n=7 Participants	1356 Participants n=5 Participants
Educational Level College graduate or higher	1343 Participants n=5 Participants	1502 Participants n=7 Participants	2845 Participants n=5 Participants
Educational Level Unknown	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Chronic coexisting conditions - number per participant	2.1 number chronic conditions per subject STANDARD_DEVIATION 1.3 • n=5 Participants	2.1 number chronic conditions per subject STANDARD_DEVIATION 1.3 • n=7 Participants	2.1 number chronic conditions per subject STANDARD_DEVIATION 1.3 • n=5 Participants
Clinically significant cognitive impairment	75 Participants n=5 Participants	85 Participants n=7 Participants	160 Participants n=5 Participants
Use of mobility aid or inability to ambulate	909 Participants n=5 Participants	972 Participants n=7 Participants	1881 Participants n=5 Participants
Number of positive responses to screening questions regarding fall injuries 1	1571 Participants n=5 Participants	1634 Participants n=7 Participants	3205 Participants n=5 Participants
Number of positive responses to screening questions regarding fall injuries 2	605 Participants n=5 Participants	629 Participants n=7 Participants	1234 Participants n=5 Participants
Number of positive responses to screening questions regarding fall injuries 3	473 Participants n=5 Participants	539 Participants n=7 Participants	1012 Participants n=5 Participants
History of fracture other than of the hip after 50 yr of age	876 Participants n=5 Participants	918 Participants n=7 Participants	1794 Participants n=5 Participants
History of hip fracture after 50 years of age	119 Participants n=5 Participants	132 Participants n=7 Participants	251 Participants n=5 Participants

PRIMARY outcome

Timeframe: Enrollment through last completed follow-up or death interview (max 44 months)

Number of first adjudicated serious fall-related injury serious fall-related injury events per 100 per years of follow-up.

Outcome measures

Outcome measures
Measure	Intervention - Fall Prevention Standard of Care n=2802 Participants An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach Evidence-based tailored fall prevention	Control n=2649 Participants Usual fall prevention care Usual care
First Adjudicated Serious Fall-Related Injury	4.87 events per 100 person years of follow-up Interval 4.31 to 5.43	5.34 events per 100 person years of follow-up Interval 4.55 to 6.13

SECONDARY outcome

Timeframe: Enrollment through last completed follow-up or death interview (max 44 months)

Number of first self-reported fall-related injuries per 100 per years of follow-up

Outcome measures

Outcome measures
Measure	Intervention - Fall Prevention Standard of Care n=2802 Participants An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach Evidence-based tailored fall prevention	Control n=2649 Participants Usual fall prevention care Usual care
First Self-reported Fall-related Injury	25.64 events per 100 person years of follow-up Interval 24.19 to 27.08	28.62 events per 100 person years of follow-up Interval 26.53 to 30.72

SECONDARY outcome

Timeframe: these data were not collected

Population: These data were not collected

\*\* data for this outcome was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores

Population: subsample selected for well-being measures with completed baseline LL-FDI

Late Life Function and Disability Instrument (LL-FDI) function score. The scores are on a 0-100 scale, higher score = better function. The measure reported is the mean of scores at the 12-month and 24-months follow-up assessment

Outcome measures

Outcome measures
Measure	Intervention - Fall Prevention Standard of Care n=380 Participants An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach Evidence-based tailored fall prevention	Control n=358 Participants Usual fall prevention care Usual care
Physical Function	58.45 units on a scale Standard Error 0.48	57.73 units on a scale Standard Error 0.51

SECONDARY outcome

Timeframe: measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores

Population: subsample selected for well-being measures with completed baseline LL-FDI

Late Life Function and Disability Instrument (LL-FDI) disability score. The scores are on a 0-100 scale, higher score = less disability. The measure reported is the mean of scores at the 12-month and 24-months follow-up assessment

Outcome measures

Outcome measures
Measure	Intervention - Fall Prevention Standard of Care n=380 Participants An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach Evidence-based tailored fall prevention	Control n=358 Participants Usual fall prevention care Usual care
Disability	55.16 units on a scale Standard Error 0.63	54.57 units on a scale Standard Error 0.67

SECONDARY outcome

Timeframe: Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.

Population: subsample selected for well-being measures and with completed baseline PROMIS Anxiety

Patient-reported Outcome Measure Information System (PROMIS) Anxiety subscale. Measured on a 8-40 Scale, higher score = more anxiety.

Outcome measures

Outcome measures
Measure	Intervention - Fall Prevention Standard of Care n=371 Participants An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach Evidence-based tailored fall prevention	Control n=350 Participants Usual fall prevention care Usual care
Anxiety	11.63 units on a scale Standard Error 0.29	12.53 units on a scale Standard Error 0.30

SECONDARY outcome

Timeframe: Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.

Population: subsample selected for well-being measures and with completed baseline PROMIS dep

PROMIS depression subscale. Measured on a 8-40 Scale, higher score = more depression.

Outcome measures

Outcome measures
Measure	Intervention - Fall Prevention Standard of Care n=372 Participants An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach Evidence-based tailored fall prevention	Control n=350 Participants Usual fall prevention care Usual care
Depression	11.75 units on a scale Standard Error 0.31	12.94 units on a scale Standard Error 0.32

SECONDARY outcome

Timeframe: Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.

Population: subsample selected for well-being measures and with completed baseline FES

Falls Efficacy Scale. Measured on a 10-40 Scale, higher score = more fear of falling.

Outcome measures

Outcome measures
Measure	Intervention - Fall Prevention Standard of Care n=372 Participants An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach Evidence-based tailored fall prevention	Control n=351 Participants Usual fall prevention care Usual care
Fear of Falling	16.03 units on a scale Standard Error 0.35	16.10 units on a scale Standard Error 0.37

Adverse Events

Intervention - Fall Prevention Standard of Care

Serious events: 1139 serious events

Other events: 0 other events

Deaths: 235 deaths

Control

Serious events: 1108 serious events

Other events: 0 other events

Deaths: 220 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Erich Greene PhD

Yale University

Phone: 203-737-3636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Intervention - Fall Prevention Standard of Care n=2802 participants at risk An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach Evidence-based tailored fall prevention	Control n=2649 participants at risk Usual fall prevention care Usual care
Blood and lymphatic system disorders hospitalization	0.86% 24/2802 • Number of events 29 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	1.1% 29/2649 • Number of events 34 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Cardiac disorders hospitalization	7.1% 199/2802 • Number of events 270 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	7.5% 199/2649 • Number of events 259 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Congenital, familial and genetic disorders hospitalization	0.04% 1/2802 • Number of events 1 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	0.08% 2/2649 • Number of events 2 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Ear and labyrinth disorders hospitalization	0.25% 7/2802 • Number of events 7 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	0.11% 3/2649 • Number of events 3 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Endocrine disorders hospitalization	0.25% 7/2802 • Number of events 7 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	0.26% 7/2649 • Number of events 8 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Eye disorders hospitalization	0.14% 4/2802 • Number of events 4 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	0.19% 5/2649 • Number of events 5 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Gastrointestinal disorders hospitalization	5.7% 161/2802 • Number of events 208 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	5.1% 135/2649 • Number of events 176 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
General disorders hospitalization	5.7% 159/2802 • Number of events 194 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	5.7% 152/2649 • Number of events 168 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Hepatobiliary disorders hospitalization	0.39% 11/2802 • Number of events 13 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	0.64% 17/2649 • Number of events 19 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Immune system disorders hospitalization	0.14% 4/2802 • Number of events 4 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	0.04% 1/2649 • Number of events 1 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Infections and infestations hospitalization	9.0% 252/2802 • Number of events 324 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	8.7% 231/2649 • Number of events 298 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Injury, poisoning and procedural complications hospitalization	6.7% 187/2802 • Number of events 225 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	7.4% 196/2649 • Number of events 242 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Investigations hospitalization	0.75% 21/2802 • Number of events 22 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	1.2% 32/2649 • Number of events 35 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Metabolism and nutrition disorders hospitalization	1.9% 54/2802 • Number of events 59 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	2.1% 55/2649 • Number of events 70 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Musculoskeletal and connective tissue disorders hospitalization	6.2% 173/2802 • Number of events 205 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	5.9% 156/2649 • Number of events 182 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) hospitalization	1.8% 51/2802 • Number of events 59 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	2.0% 52/2649 • Number of events 58 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Nervous system disorders hospitalization	6.4% 178/2802 • Number of events 230 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	5.8% 153/2649 • Number of events 192 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Psychiatric disorders hospitalization	0.93% 26/2802 • Number of events 31 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	0.91% 24/2649 • Number of events 30 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Renal and urinary disorders hospitalization	1.8% 51/2802 • Number of events 54 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	2.1% 55/2649 • Number of events 67 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Reproductive system and breast disorders hospitalization	0.29% 8/2802 • Number of events 8 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	0.23% 6/2649 • Number of events 6 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Respiratory, thoracic and mediastinal disorders hospitalization	5.6% 156/2802 • Number of events 196 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	4.5% 119/2649 • Number of events 156 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Skin and subcutaneous tissue disorders hospitalization	0.18% 5/2802 • Number of events 6 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	0.23% 6/2649 • Number of events 6 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Social circumstances hospitalization	0.18% 5/2802 • Number of events 6 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	0.08% 2/2649 • Number of events 2 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Vascular disorders hospitalization	2.2% 63/2802 • Number of events 72 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	2.9% 77/2649 • Number of events 91 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.
Pregnancy, puerperium and perinatal conditions hospitalization	0.00% 0/2802 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.	0.04% 1/2649 • Number of events 1 • Enrollment through death, withdrawal, or end of study (max 44 months) Only SAEs (death and hospitalization) were recorded. AEs were not collected in this pragmatic trial.