Trial Outcomes & Findings for Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management (NCT NCT05400837)

NCT ID: NCT05400837

Last Updated: 2025-07-03

Results Overview

Feasibility assessed by retention at 12 weeks (number of individuals who continue study participation (defined by App interaction, Coaching call participation or follow up survey completion)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 61 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2025-07-03

Participant Flow

Participants were recruited from outpatient electrophysiology clinics at Johns Hopkins Hospital. A study coordinator reviewed EMRs and let clinicians know which patients were eligible. The clinician introduced the patient to the study, and if they were interested, the study coordinator talked to the patient after their appointment. Interested patients signed informed consent, were randomized, and onboarded to the study the same day.

Participants were assigned their group immediately after signing consent.

Participant milestones

Measure	Corrie Virtual Atrial Fibrillation Management Program Multicomponent virtual atrial fibrillation management program	Usual Care Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Overall Study STARTED	30	31
Overall Study COMPLETED	25	29
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data was excluded for one participant who asked to have their data deleted from the study.

Baseline characteristics by cohort

Measure	Corrie Virtual Atrial Fibrillation Management Program n=30 Participants Multicomponent virtual atrial fibrillation management program	Usual Care n=30 Participants Receives usual care. Usual care is defined as care according to the patients care team's standard practice	Total n=60 Participants Total of all reporting groups
Age, Continuous	65 years n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	69 years n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	67.5 years n=60 Participants • Data was excluded for one participant who asked to have their data deleted from the study.
Sex: Female, Male Female	10 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	13 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	23 Participants n=60 Participants • Data was excluded for one participant who asked to have their data deleted from the study.
Sex: Female, Male Male	20 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	17 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	37 Participants n=60 Participants • Data was excluded for one participant who asked to have their data deleted from the study.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	0 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	0 Participants n=60 Participants • Data was excluded for one participant who asked to have their data deleted from the study.
Race (NIH/OMB) Asian	1 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	2 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	3 Participants n=60 Participants • Data was excluded for one participant who asked to have their data deleted from the study.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	0 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	0 Participants n=60 Participants • Data was excluded for one participant who asked to have their data deleted from the study.
Race (NIH/OMB) Black or African American	2 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	0 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	2 Participants n=60 Participants • Data was excluded for one participant who asked to have their data deleted from the study.
Race (NIH/OMB) White	26 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	28 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	54 Participants n=60 Participants • Data was excluded for one participant who asked to have their data deleted from the study.
Race (NIH/OMB) More than one race	1 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	0 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	1 Participants n=60 Participants • Data was excluded for one participant who asked to have their data deleted from the study.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	0 Participants n=30 Participants • Data was excluded for one participant who asked to have their data deleted from the study.	0 Participants n=60 Participants • Data was excluded for one participant who asked to have their data deleted from the study.
Quality of life as assessed by the Atrial Fibrillation Effect on Quality-of-Life	78.7 Survey score STANDARD_DEVIATION 24.1 • n=23 Participants • Some participants chose not to complete this questionnaire.	73.1 Survey score STANDARD_DEVIATION 31.1 • n=29 Participants • Some participants chose not to complete this questionnaire.	75.6 Survey score STANDARD_DEVIATION 28.0 • n=52 Participants • Some participants chose not to complete this questionnaire.
Atrial Fibrillation (AF) Severity as assessed by the Atrial Fibrillation Severity Scale AF burden subscore	12.8 Survey score STANDARD_DEVIATION 5.4 • n=23 Participants • Some participants chose not to complete this questionnaire	13.2 Survey score STANDARD_DEVIATION 3.7 • n=29 Participants • Some participants chose not to complete this questionnaire	13.0 Survey score STANDARD_DEVIATION 4.5 • n=52 Participants • Some participants chose not to complete this questionnaire
Atrial Fibrillation (AF) Severity as assessed by the Atrial Fibrillation Severity Scale AF duration subscore	4.1 Survey score STANDARD_DEVIATION 2.8 • n=23 Participants • Some participants chose not to complete this questionnaire	4.3 Survey score STANDARD_DEVIATION 2.1 • n=30 Participants • Some participants chose not to complete this questionnaire	4.2 Survey score STANDARD_DEVIATION 2.4 • n=53 Participants • Some participants chose not to complete this questionnaire
Atrial Fibrillation (AF) Severity as assessed by the Atrial Fibrillation Severity Scale AF severity subscore	5.3 Survey score STANDARD_DEVIATION 2.7 • n=23 Participants • Some participants chose not to complete this questionnaire	5.4 Survey score STANDARD_DEVIATION 2.3 • n=30 Participants • Some participants chose not to complete this questionnaire	5.4 Survey score STANDARD_DEVIATION 2.5 • n=53 Participants • Some participants chose not to complete this questionnaire
Atrial Fibrillation (AF) Severity as assessed by the Atrial Fibrillation Severity Scale AF frequency subscore	3.0 Survey score STANDARD_DEVIATION 3.0 • n=23 Participants • Some participants chose not to complete this questionnaire	3.4 Survey score STANDARD_DEVIATION 1.8 • n=30 Participants • Some participants chose not to complete this questionnaire	3.2 Survey score STANDARD_DEVIATION 2.5 • n=53 Participants • Some participants chose not to complete this questionnaire
Atrial Fibrillation (AF) Severity as assessed by the Atrial Fibrillation Severity Scale AF symptoms subscore	6.3 Survey score STANDARD_DEVIATION 5.3 • n=23 Participants • Some participants chose not to complete this questionnaire	7.9 Survey score STANDARD_DEVIATION 6.5 • n=30 Participants • Some participants chose not to complete this questionnaire	7.2 Survey score STANDARD_DEVIATION 6.0 • n=53 Participants • Some participants chose not to complete this questionnaire
Skills in applying electronic health information to health problems	38.2 Survey score STANDARD_DEVIATION 4.8 • n=23 Participants • Some participants chose not to complete this questionnaire	40.2 Survey score STANDARD_DEVIATION 4.9 • n=30 Participants • Some participants chose not to complete this questionnaire	39.3 Survey score STANDARD_DEVIATION 4.9 • n=53 Participants • Some participants chose not to complete this questionnaire
Depressive symptoms as assessed by the Patient Health Questionnaire 8	1.0 Survey score STANDARD_DEVIATION 5.0 • n=21 Participants • Some participants chose not to complete this questionnaire	2.0 Survey score STANDARD_DEVIATION 5.0 • n=30 Participants • Some participants chose not to complete this questionnaire	1.6 Survey score STANDARD_DEVIATION 5.0 • n=51 Participants • Some participants chose not to complete this questionnaire
Anxiety as assessed by the Generalized Anxiety Disorder 7 score	0 Survey score STANDARD_DEVIATION 4.0 • n=23 Participants • Some participants chose not to complete this questionnaire	2.0 Survey score STANDARD_DEVIATION 4.0 • n=30 Participants • Some participants chose not to complete this questionnaire	1.1 Survey score STANDARD_DEVIATION 4.0 • n=53 Participants • Some participants chose not to complete this questionnaire
Stress level as assessed by the Perceived Stress Score	10.1 Survey score STANDARD_DEVIATION 5.1 • n=21 Participants • Some participants chose not to complete this questionnaire	10.0 Survey score STANDARD_DEVIATION 13.0 • n=30 Participants • Some participants chose not to complete this questionnaire	10.0 Survey score STANDARD_DEVIATION 9.5 • n=51 Participants • Some participants chose not to complete this questionnaire
Alcohol use as assessed by the Alcohol Use Disorders Identification Test	2.0 Survey score STANDARD_DEVIATION 2.5 • n=23 Participants • Some participants chose not to complete this questionnaire	2.0 Survey score STANDARD_DEVIATION 3.0 • n=30 Participants • Some participants chose not to complete this questionnaire	2.0 Survey score STANDARD_DEVIATION 2.8 • n=53 Participants • Some participants chose not to complete this questionnaire
Physical Activity as assessed by the Rapid Assessment of Physical Activity RAPA Part 1 score	5.0 Survey score STANDARD_DEVIATION 1.0 • n=23 Participants • Some participants chose not to complete this questionnaire	5.0 Survey score STANDARD_DEVIATION 1.0 • n=30 Participants • Some participants chose not to complete this questionnaire	5.0 Survey score STANDARD_DEVIATION 1.0 • n=53 Participants • Some participants chose not to complete this questionnaire
Physical Activity as assessed by the Rapid Assessment of Physical Activity RAPA Part 2 score	1.0 Survey score STANDARD_DEVIATION 2.0 • n=23 Participants • Some participants chose not to complete this questionnaire	2.0 Survey score STANDARD_DEVIATION 3.0 • n=30 Participants • Some participants chose not to complete this questionnaire	1.6 Survey score STANDARD_DEVIATION 2.6 • n=53 Participants • Some participants chose not to complete this questionnaire

PRIMARY outcome

Timeframe: 12 weeks

Feasibility assessed by retention at 12 weeks (number of individuals who continue study participation (defined by App interaction, Coaching call participation or follow up survey completion)

Outcome measures

Measure	Corrie Virtual Atrial Fibrillation Management Program n=30 Participants Multicomponent virtual atrial fibrillation management program	Usual Care n=31 Participants Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Number of Participants Who Continue Study Participation at 12 Weeks	26 Participants	29 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Some participants chose not to complete this survey.

Measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT), which consists of 20 items. Score ranges from 0 to 100 with higher scores signifying better quality of life.

Outcome measures

Measure	Corrie Virtual Atrial Fibrillation Management Program n=23 Participants Multicomponent virtual atrial fibrillation management program	Usual Care n=29 Participants Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life	87.0 score on a scale Standard Deviation 24.1	76.0 score on a scale Standard Deviation 31.5

SECONDARY outcome

Timeframe: 12 weeks

Population: Some participants chose not to complete this survey

Measured by the Atrial Fibrillation Severity Scale (AFSS) - validated 19 item questionnaire. Includes 5 subscores. AF burden is the sum of AF duration, AF severity, and AF frequency, and ranges from 3 to 30, with 30 being highest burden. AF duration, severity, and frequency each range from 1 to 10. The final subscore is AF symptoms, which ranges from 0-35 with 35 indicating worst possible symptoms.

Outcome measures

Measure	Corrie Virtual Atrial Fibrillation Management Program n=23 Participants Multicomponent virtual atrial fibrillation management program	Usual Care n=29 Participants Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale AF burden score (sum of duration, severity, and frequency subscores)	11.3 score on a scale Standard Deviation 4.5	12.7 score on a scale Standard Deviation 5.0
Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale AF duration score	3.1 score on a scale Standard Deviation 2.4	4.3 score on a scale Standard Deviation 2.7
Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale AF severity score	4.6 score on a scale Standard Deviation 2.8	5.4 score on a scale Standard Deviation 2.6
Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale AF frequency score	3.6 score on a scale Standard Deviation 2.5	3.0 score on a scale Standard Deviation 1.7
Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale AF symptoms score	3.0 score on a scale Standard Deviation 4.0	7.6 score on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: 12 weeks

Population: Some participants chose not to complete this survey

Measured by 8-item questionnaire eHealth Literacy Scale. Scores range from 10-50 with a higher score indicating higher electronic health literacy.

Outcome measures

Measure	Corrie Virtual Atrial Fibrillation Management Program n=23 Participants Multicomponent virtual atrial fibrillation management program	Usual Care n=29 Participants Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Skills in Applying Electronic Health Information to Health Problems	40.0 score on a scale Standard Deviation 4.0	40.1 score on a scale Standard Deviation 5.6

SECONDARY outcome

Timeframe: 12 weeks

Population: Some participants chose not to complete this survey

Measured by Patient Health Questionnaire 8 (PHQ - 8) - 8-item measure with (≤4: no depressive symptom, 5-9: mild, ≥10: moderate to severe depressive symptoms). Score range 0-27 with higher score indicating more depressive symptoms.

Outcome measures

Measure	Corrie Virtual Atrial Fibrillation Management Program n=21 Participants Multicomponent virtual atrial fibrillation management program	Usual Care n=29 Participants Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Depressive Symptoms as Assessed by the Patient Health Questionnaire 8	1.0 Survey score Standard Deviation 4.0	3.0 Survey score Standard Deviation 3.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Some participants chose not to complete this survey

Generalized Anxiety Disorder 7 (GAD 7) - score ranges from 0 to 21 with higher scores indicating more anxiety.

Outcome measures

Measure	Corrie Virtual Atrial Fibrillation Management Program n=23 Participants Multicomponent virtual atrial fibrillation management program	Usual Care n=29 Participants Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score	1.0 score on a scale Standard Deviation 2.0	1.0 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Some participants chose not to complete this survey

Measured by Perceived Stress Score (PSS-10), 10 item questionnaire where score ranges from 0-40 with higher scores indicating higher level of stress.

Outcome measures

Measure	Corrie Virtual Atrial Fibrillation Management Program n=23 Participants Multicomponent virtual atrial fibrillation management program	Usual Care n=29 Participants Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Stress Level as Assessed by the Perceived Stress Score	10.1 score on a scale Standard Deviation 5.1	11.5 score on a scale Standard Deviation 8.1

SECONDARY outcome

Timeframe: 12 weeks

Population: Some participants chose not to complete this survey

Physical Activity will be assessed by The Rapid Assessment of Physical Activity (RAPA). Part 1 scores range from 1-5 with increasing scores indicating higher levels of activity, 5 being optimal. Part 2 is scored from 0-3 and measures the amount of flexibility and calisthenics exercise a person completes, with 3 being optimal.

Outcome measures

Measure	Corrie Virtual Atrial Fibrillation Management Program n=23 Participants Multicomponent virtual atrial fibrillation management program	Usual Care n=29 Participants Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Physical Activity as Assessed by the Rapid Assessment of Physical Activity RAPA Part 1 score	5.0 Survey score Standard Deviation 0.5	5.0 Survey score Standard Deviation 1.0
Physical Activity as Assessed by the Rapid Assessment of Physical Activity RAPA Part 2 score	1.0 Survey score Standard Deviation 2.0	2.0 Survey score Standard Deviation 3.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Some participants chose not to complete this survey

As assessed by The Alcohol Use Disorders Identification Test (AUDIT), 10-item questionnaire. The score range is from 0 to 40 with 0 referring to abstainer with no history of alcohol abuse and higher scores indicate gradually higher and hazardous alcohol dependence.

Outcome measures

Measure	Corrie Virtual Atrial Fibrillation Management Program n=23 Participants Multicomponent virtual atrial fibrillation management program	Usual Care n=29 Participants Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Alcohol Use as Assessed by the Alcohol Use Disorders Identification Test	2.0 score on a scale Standard Deviation 2.0	2.0 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Some participants chose not to complete this survey

Measured by Rate Your Plate (RYP) scale. A 27 item scale administered at 12 weeks with the following scoring system: Score ranges from 27-81.

Score of 27-45: There are many ways you can make your eating habits healthier. 46-63: There are some ways you can make your eating habits healthier. 64-81: Higher score indicates participant is making many healthy choices.

Outcome measures

Measure	Corrie Virtual Atrial Fibrillation Management Program n=23 Participants Multicomponent virtual atrial fibrillation management program	Usual Care n=29 Participants Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Diet as Assessed by the Rate Your Plate (RYP) Scale	65.1 Survey score Standard Deviation 5.3	64.0 Survey score Standard Deviation 6.2

SECONDARY outcome

Timeframe: 12 weeks

Population: Some participants did not complete the 12-week follow-up visit where blood pressure was assessed.

Measured in millimeters of mercury (mmHg).

Outcome measures

Measure	Corrie Virtual Atrial Fibrillation Management Program n=24 Participants Multicomponent virtual atrial fibrillation management program	Usual Care n=28 Participants Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Blood Pressure Systolic blood pressure	123.1 mmHg Standard Deviation 16.3	123.3 mmHg Standard Deviation 14.2
Blood Pressure Diastolic blood pressure	75.6 mmHg Standard Deviation 8.7	73.4 mmHg Standard Deviation 9.9

SECONDARY outcome

Timeframe: 12 weeks

Population: Not all participants completed the 12-week follow-up visit where weight was measured.

Measured in kilograms over meter squared (Kg/m^2).

Outcome measures

Measure	Corrie Virtual Atrial Fibrillation Management Program n=24 Participants Multicomponent virtual atrial fibrillation management program	Usual Care n=29 Participants Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Body Mass Index (BMI)	29.6 kg/m^2 Standard Deviation 4.8	29.9 kg/m^2 Standard Deviation 7.0

SECONDARY outcome

Timeframe: 12 weeks

Population: Participants in usual care did not receive intervention and so did not rate their satisfaction. Not all participants in the intervention chose to complete the survey.

Measured by the System Usability Scale (SUS), modified for the intervention. The SUS score ranges from 0-100, where 0 is "worst imaginable" and 100 is "best imaginable." The average score is 68.0, a good score is between 71.4-85.4. 85.5 and above is considered excellent. Higher score more satisfaction.

Outcome measures

Measure	Corrie Virtual Atrial Fibrillation Management Program n=20 Participants Multicomponent virtual atrial fibrillation management program	Usual Care Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Satisfaction With Intervention	78.25 score on a scale Interval 70.5 to 86.75	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Studies were completed one time between enrollment and end of treatment at 12 weeks

Population: The control group did not complete a sleep study. Not all members of the intervention group chose to complete the sleep study.

Patients completed an at-home sleep study and received a diagnosis of no sleep apnea, mild sleep apnea, moderate sleep apnea, or severe sleep apnea, based on their AHI (apnea-hypopnea index). AHI is measured in breathing disturbance events per hour. An AHI <5 indicates no sleep apnea, from 5-15 is mild, 16-30 is moderate, and >30 is severe sleep apnea.

Outcome measures

Measure	Corrie Virtual Atrial Fibrillation Management Program n=26 Participants Multicomponent virtual atrial fibrillation management program	Usual Care Receives usual care. Usual care is defined as care according to the patients care team's standard practice
At-home Sleep Study Results Diagnosed with mild sleep apnea	4 Participants	0 Participants
At-home Sleep Study Results Diagnosed with moderate to severe sleep apnea	8 Participants	0 Participants
At-home Sleep Study Results Not diagnosed with sleep apnea	14 Participants	0 Participants

Adverse Events

Corrie Virtual Atrial Fibrillation Management Program

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Corrie Virtual Atrial Fibrillation Management Program n=30 participants at risk Multicomponent virtual atrial fibrillation management program Corrie Virtual Atrial Fibrillation Management Program: Intervention aims to implement guideline-recommended Afib care	Usual Care n=31 participants at risk Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Cardiac disorders Pulmonary embolism	3.3% 1/30 • Number of events 1 • From enrollment until end of follow-up, up to 12 weeks The investigators asked participants to report any adverse events up to the end of follow-up (12 weeks). Adverse events were adjudicated by the principal investigator.	0.00% 0/31 • From enrollment until end of follow-up, up to 12 weeks The investigators asked participants to report any adverse events up to the end of follow-up (12 weeks). Adverse events were adjudicated by the principal investigator.

Other adverse events

Measure	Corrie Virtual Atrial Fibrillation Management Program n=30 participants at risk Multicomponent virtual atrial fibrillation management program Corrie Virtual Atrial Fibrillation Management Program: Intervention aims to implement guideline-recommended Afib care	Usual Care n=31 participants at risk Receives usual care. Usual care is defined as care according to the patients care team's standard practice
General disorders Hospitalization	6.7% 2/30 • Number of events 2 • From enrollment until end of follow-up, up to 12 weeks The investigators asked participants to report any adverse events up to the end of follow-up (12 weeks). Adverse events were adjudicated by the principal investigator.	6.5% 2/31 • Number of events 2 • From enrollment until end of follow-up, up to 12 weeks The investigators asked participants to report any adverse events up to the end of follow-up (12 weeks). Adverse events were adjudicated by the principal investigator.
General disorders Emergency department visit	3.3% 1/30 • Number of events 1 • From enrollment until end of follow-up, up to 12 weeks The investigators asked participants to report any adverse events up to the end of follow-up (12 weeks). Adverse events were adjudicated by the principal investigator.	6.5% 2/31 • Number of events 2 • From enrollment until end of follow-up, up to 12 weeks The investigators asked participants to report any adverse events up to the end of follow-up (12 weeks). Adverse events were adjudicated by the principal investigator.
Injury, poisoning and procedural complications Fall	3.3% 1/30 • Number of events 1 • From enrollment until end of follow-up, up to 12 weeks The investigators asked participants to report any adverse events up to the end of follow-up (12 weeks). Adverse events were adjudicated by the principal investigator.	3.2% 1/31 • Number of events 1 • From enrollment until end of follow-up, up to 12 weeks The investigators asked participants to report any adverse events up to the end of follow-up (12 weeks). Adverse events were adjudicated by the principal investigator.

Additional Information

Nino Isakadze

Johns Hopkins University

Phone: 443-997-0270

Email: nisakad1@jh.edu

Results disclosure agreements

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