Trial Outcomes & Findings for Walking and mHealth to Increase Participation in Parkinson Disease (NCT NCT03517371)

Last Updated: 2025-03-26

Results Overview

Change in the average number of steps walked per day over the one year study. Participants wore the step watch for one week before starting the program as part of their baseline visit and one week at the end of the year program as part of their 12-month visit. Daily steps were averaged at baseline and 12-month and a change score was computed (average of daily steps at 12-Months minus average of daily steps at baseline).

Recruitment status

COMPLETED

Study phase

Target enrollment

140 participants

Primary outcome timeframe

12 months

Results posted on

2025-03-26

Participant Flow

Recruitment began in February 2019 and concluded in March 2023. We experienced pauses in recruiting new participants during COVID 2020-2021. For already enrolled participants, we continued collection of measures that could be done remotely. Recruitment was via flyers which were available at physical therapy clinics, movement disorder clinics, support groups, and health fairs and events.

Participants were excluded during in-person screening if they had significant cognitive impairment (Mini-Mental Status Examination \< 24), disturbing freezing of gait episodes during daily walking (score of ≥ 2 on item 7 of New Freezing of Gait Questionnaire, resting tachycardia (\>120 beats/min), uncontrolled BP (resting systolic BP\>180 mmHg or diastolic BP\>100 mmHg)), unstable medical illnesses or conditions that would preclude successful participation, and/or Modified Hoehn \& Yahr stage \>3.

Participant milestones

Participant milestones
Measure	mHealth Delivered Exercise Program Participants in the mHealth delivered exercise program have up to 8 in-person visits with a physical therapist over 12 months. The mHealth exercise program, consisting of walking, strengthening and stretching exercises, is prescribed and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week. The exercise program is video-recorded and accessed on a smartphone or computer tablet via an application ("app"). Cognitive-behavioral elements are integrated emphasizing participant engagement in managing their health condition. Components of the mHealth program include goal setting, action planning, automated rewards, self-monitoring of progress and a remote connection to a physical therapist through a messaging feature.	Exercise Only Participants in the control group have up to 8 in-person visits with a physical therapist over 12-months - equivalent to the dose provided to the mHealth condition. Participants are instructed by the physical therapist to engage in walking and perform the same progressive resistance and stretching exercises (tailored to their needs and provided in written format) at the same frequency (5x/week) as participants in the mHealth condition. Participants in the control condition are instructed to gradually progress their exercise program and to increase the amount of walking over a 1-year period. No cognitive-behavioral approaches or mHealth technology will be provided.
Overall Study STARTED	73	67
Overall Study COMPLETED	58	48
Overall Study NOT COMPLETED	15	19

Reasons for withdrawal

Reasons for withdrawal
Measure	mHealth Delivered Exercise Program Participants in the mHealth delivered exercise program have up to 8 in-person visits with a physical therapist over 12 months. The mHealth exercise program, consisting of walking, strengthening and stretching exercises, is prescribed and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week. The exercise program is video-recorded and accessed on a smartphone or computer tablet via an application ("app"). Cognitive-behavioral elements are integrated emphasizing participant engagement in managing their health condition. Components of the mHealth program include goal setting, action planning, automated rewards, self-monitoring of progress and a remote connection to a physical therapist through a messaging feature.	Exercise Only Participants in the control group have up to 8 in-person visits with a physical therapist over 12-months - equivalent to the dose provided to the mHealth condition. Participants are instructed by the physical therapist to engage in walking and perform the same progressive resistance and stretching exercises (tailored to their needs and provided in written format) at the same frequency (5x/week) as participants in the mHealth condition. Participants in the control condition are instructed to gradually progress their exercise program and to increase the amount of walking over a 1-year period. No cognitive-behavioral approaches or mHealth technology will be provided.
Overall Study Adverse Event	8	9
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	4	4
Overall Study Not idiopathic Parkinson's disease	0	3
Overall Study COVID restrictions	2	0
Overall Study Receiving DBS Surgery	0	1

Baseline Characteristics

Walking and mHealth to Increase Participation in Parkinson Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	mHealth Delivered Exercise Program n=73 Participants Participants in the mHealth delivered exercise program have up to 8 in-person visits with a physical therapist over 12 months. The mHealth exercise program, consisting of walking, strengthening and stretching exercises, is prescribed and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week. The exercise program is video-recorded and accessed on a smartphone or computer tablet via an application ("app"). Cognitive-behavioral elements are integrated emphasizing participant engagement in managing their health condition. Components of the mHealth program include goal setting, action planning, automated rewards, self-monitoring of progress and a remote connection to a physical therapist through a messaging feature.	Exercise Only n=67 Participants Participants in the control group have up to 8 in-person visits with a physical therapist over 12-months - equivalent to the dose provided to the mHealth condition. Participants are instructed by the physical therapist to engage in walking and perform the same progressive resistance and stretching exercises (tailored to their needs and provided in written format) at the same frequency (5x/week) as participants in the mHealth condition. Participants in the control condition are instructed to gradually progress their exercise program and to increase the amount of walking over a 1-year period. No cognitive-behavioral approaches or mHealth technology will be provided.	Total n=140 Participants Total of all reporting groups
Age, Continuous	68.25 age, continuous, in years STANDARD_DEVIATION 8.37 • n=5 Participants	67.21 age, continuous, in years STANDARD_DEVIATION 7.79 • n=7 Participants	67.75 age, continuous, in years STANDARD_DEVIATION 8.08 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	32 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	35 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	69 Participants n=5 Participants	63 Participants n=7 Participants	132 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=5 Participants	67 Participants n=7 Participants	138 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: There were 15 participants who withdrew in mHealth group and 19 participant who withdrew in the exercise group. In addition, one participant was missing daily step data at random at 12 months in mHealth, and one participant was missing data due to a technical issue with the step watch in the exercise group.

Outcome measures

Outcome measures
Measure	mHealth Delivered Exercise Program n=57 Participants Participants in the mHealth delivered exercise program have up to 8 in-person visits with a physical therapist over 12 months. The mHealth exercise program, consisting of walking, strengthening and stretching exercises, is prescribed and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week. The exercise program is video-recorded and accessed on a smartphone or computer tablet via an application ("app"). Cognitive-behavioral elements are integrated emphasizing participant engagement in managing their health condition. Components of the mHealth program include goal setting, action planning, automated rewards, self-monitoring of progress and a remote connection to a physical therapist through a messaging feature.	Exercise Only n=47 Participants Participants in the control group have up to 8 in-person visits with a physical therapist over 12-months - equivalent to the dose provided to the mHealth condition. Participants are instructed by the physical therapist to engage in walking and perform the same progressive resistance and stretching exercises (tailored to their needs and provided in written format) at the same frequency (5x/week) as participants in the mHealth condition. Participants in the control condition are instructed to gradually progress their exercise program and to increase the amount of walking over a 1-year period. No cognitive-behavioral approaches or mHealth technology will be provided.
Walking Activity	-207.59 change in average daily steps Standard Deviation 2749.39	-135.24 change in average daily steps Standard Deviation 2403.17

PRIMARY outcome

Timeframe: 12 months

Change in the average number of moderate intensity minutes over the one year study. Moderate intensity minutes is defined as the number of minutes in which \>100 steps were accumulated. Participants wore the step watch for one week before starting the program as part of their baseline visit and one week at the end of the year program as part of their 12-month visit. Moderate intensity minutes were averaged at baseline and 12-month and a change score was computed (average of moderate intensity minutes at 12-Months minus average of moderate intensity minutes at baseline).

Outcome measures

Outcome measures
Measure	mHealth Delivered Exercise Program n=57 Participants Participants in the mHealth delivered exercise program have up to 8 in-person visits with a physical therapist over 12 months. The mHealth exercise program, consisting of walking, strengthening and stretching exercises, is prescribed and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week. The exercise program is video-recorded and accessed on a smartphone or computer tablet via an application ("app"). Cognitive-behavioral elements are integrated emphasizing participant engagement in managing their health condition. Components of the mHealth program include goal setting, action planning, automated rewards, self-monitoring of progress and a remote connection to a physical therapist through a messaging feature.	Exercise Only n=47 Participants Participants in the control group have up to 8 in-person visits with a physical therapist over 12-months - equivalent to the dose provided to the mHealth condition. Participants are instructed by the physical therapist to engage in walking and perform the same progressive resistance and stretching exercises (tailored to their needs and provided in written format) at the same frequency (5x/week) as participants in the mHealth condition. Participants in the control condition are instructed to gradually progress their exercise program and to increase the amount of walking over a 1-year period. No cognitive-behavioral approaches or mHealth technology will be provided.
Walking Intensity	1.67 change in average moderate intensity min Standard Deviation 9.41	1.33 change in average moderate intensity min Standard Deviation 8.07

SECONDARY outcome

Timeframe: 12 months

Population: There were 15 participants who withdrew in the mHealth group and 19 participants who withdrew in the exercise group. Due to COVID restrictions, we were unable to complete measures that required participants to come in-person, thus we are missing data on this measure for 17 more people in the mHealth group and 19 more people in the exercise group. In addition, one participant in mHealth and one participant in exercise group did not complete this measure at 12-month due to physical reasons.

Change in the number of meters walked during the six-minute walk test over the one year study. The distance in meters is reported. Participants completed the six-minute walk before starting the program as part of their baseline visit and at the end of the year program as part of their 12-month visit. A change score was computed - the number of meters walked at 12 months minus the number of meters walked at baseline).

Outcome measures

Outcome measures
Measure	mHealth Delivered Exercise Program n=40 Participants Participants in the mHealth delivered exercise program have up to 8 in-person visits with a physical therapist over 12 months. The mHealth exercise program, consisting of walking, strengthening and stretching exercises, is prescribed and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week. The exercise program is video-recorded and accessed on a smartphone or computer tablet via an application ("app"). Cognitive-behavioral elements are integrated emphasizing participant engagement in managing their health condition. Components of the mHealth program include goal setting, action planning, automated rewards, self-monitoring of progress and a remote connection to a physical therapist through a messaging feature.	Exercise Only n=28 Participants Participants in the control group have up to 8 in-person visits with a physical therapist over 12-months - equivalent to the dose provided to the mHealth condition. Participants are instructed by the physical therapist to engage in walking and perform the same progressive resistance and stretching exercises (tailored to their needs and provided in written format) at the same frequency (5x/week) as participants in the mHealth condition. Participants in the control condition are instructed to gradually progress their exercise program and to increase the amount of walking over a 1-year period. No cognitive-behavioral approaches or mHealth technology will be provided.
Walking Capacity - Six Minute Walk Distance	15.63 change in meters walked Standard Deviation 57.02	17.79 change in meters walked Standard Deviation 37.12

SECONDARY outcome

Timeframe: 12 months

Population: There were 15 participants who withdrew in the mHealth group and 19 participants who withdrew in the exercise group. Due to COVID restrictions, we were unable to complete measures that required participants to come in-person, thus we are missing data on this measure for 17 more people in the mHealth group and 19 more people in the exercise group. In addition, one participant in mHealth did not complete this measure at 12 months due to physical reasons.

Change in the number of meters per second walked during the ten-meter walk test (comfortable forward pace) over the one year study. The distance in meters per second are reported. Participants completed the ten-meter walk test before starting the program as part of their baseline visit and at the end of the year program as part of their 12-month visit. A change score was computed - the number of meters per second walked at 12-months minus the number of meters per second walked at baseline).

Outcome measures

Outcome measures
Measure	mHealth Delivered Exercise Program n=40 Participants Participants in the mHealth delivered exercise program have up to 8 in-person visits with a physical therapist over 12 months. The mHealth exercise program, consisting of walking, strengthening and stretching exercises, is prescribed and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week. The exercise program is video-recorded and accessed on a smartphone or computer tablet via an application ("app"). Cognitive-behavioral elements are integrated emphasizing participant engagement in managing their health condition. Components of the mHealth program include goal setting, action planning, automated rewards, self-monitoring of progress and a remote connection to a physical therapist through a messaging feature.	Exercise Only n=29 Participants Participants in the control group have up to 8 in-person visits with a physical therapist over 12-months - equivalent to the dose provided to the mHealth condition. Participants are instructed by the physical therapist to engage in walking and perform the same progressive resistance and stretching exercises (tailored to their needs and provided in written format) at the same frequency (5x/week) as participants in the mHealth condition. Participants in the control condition are instructed to gradually progress their exercise program and to increase the amount of walking over a 1-year period. No cognitive-behavioral approaches or mHealth technology will be provided.
Walking Capacity - Ten Meter Walk Test	.027 change in meters per second Standard Deviation .146	.019 change in meters per second Standard Deviation .154

Adverse Events

mHealth Delivered Exercise Program

Serious events: 15 serious events

Other events: 39 other events

Deaths: 0 deaths

Exercise Only

Serious events: 17 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	mHealth Delivered Exercise Program n=73 participants at risk Participants in the mHealth delivered exercise program have up to 8 in-person visits with a physical therapist over 12 months. The mHealth exercise program, consisting of walking, strengthening and stretching exercises, is prescribed and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week. The exercise program is video-recorded and accessed on a smartphone or computer tablet via an application ("app"). Cognitive-behavioral elements are integrated emphasizing participant engagement in managing their health condition. Components of the mHealth program include goal setting, action planning, automated rewards, self-monitoring of progress and a remote connection to a physical therapist through a messaging feature. mHealth delivered exercise program: Participants in the mobile health condition have up to 8 in-person visits with a physical therapist over 12 months. The exercise program, consisting of walking, strengthening and stretching exercises, is prescribed through an "app" and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week.	Exercise Only n=67 participants at risk Participants in the control group have up to 8 in-person visits with a physical therapist over 12-months - equivalent to the dose provided to the mHealth condition. Participants are instructed by the physical therapist to engage in walking and perform the same progressive resistance and stretching exercises (tailored to their needs and provided in written format) at the same frequency (5x/week) as participants in the mHealth condition. Participants in the control condition are instructed to gradually progress their exercise program and to increase the amount of walking over a 1-year period. No cognitive-behavioral approaches or mHealth technology will be provided. Exercise only: Participants in the control group have up to 8 in-person visits with the intervention physical therapist over 12-months. Participants are instructed by the physical therapist to engage in walking and perform progressive resistance and stretching exercises (tailored to their needs and provided in written format) 5 days per week.
Injury, poisoning and procedural complications Fall	20.5% 15/73 • Number of events 19 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	20.9% 14/67 • Number of events 17 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Musculoskeletal and connective tissue disorders Back Pain	6.8% 5/73 • Number of events 5 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	10.4% 7/67 • Number of events 7 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Musculoskeletal and connective tissue disorders Pain in Extremity	26.0% 19/73 • Number of events 24 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	20.9% 14/67 • Number of events 18 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.

Additional Information

Terry Ellis

Center for Neurorehabilitation, College of Health & Rehabilitation, Sargent College, Boston University

Phone: 617-353-2724

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	mHealth Delivered Exercise Program n=73 participants at risk Participants in the mHealth delivered exercise program have up to 8 in-person visits with a physical therapist over 12 months. The mHealth exercise program, consisting of walking, strengthening and stretching exercises, is prescribed and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week. The exercise program is video-recorded and accessed on a smartphone or computer tablet via an application ("app"). Cognitive-behavioral elements are integrated emphasizing participant engagement in managing their health condition. Components of the mHealth program include goal setting, action planning, automated rewards, self-monitoring of progress and a remote connection to a physical therapist through a messaging feature. mHealth delivered exercise program: Participants in the mobile health condition have up to 8 in-person visits with a physical therapist over 12 months. The exercise program, consisting of walking, strengthening and stretching exercises, is prescribed through an "app" and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week.	Exercise Only n=67 participants at risk Participants in the control group have up to 8 in-person visits with a physical therapist over 12-months - equivalent to the dose provided to the mHealth condition. Participants are instructed by the physical therapist to engage in walking and perform the same progressive resistance and stretching exercises (tailored to their needs and provided in written format) at the same frequency (5x/week) as participants in the mHealth condition. Participants in the control condition are instructed to gradually progress their exercise program and to increase the amount of walking over a 1-year period. No cognitive-behavioral approaches or mHealth technology will be provided. Exercise only: Participants in the control group have up to 8 in-person visits with the intervention physical therapist over 12-months. Participants are instructed by the physical therapist to engage in walking and perform progressive resistance and stretching exercises (tailored to their needs and provided in written format) 5 days per week.
Eye disorders Retinal Detachment	0.00% 0/73 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	1.5% 1/67 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Gastrointestinal disorders Esophageal Spasm	0.00% 0/73 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	1.5% 1/67 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
General disorders Gait Disturbance	0.00% 0/73 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	1.5% 1/67 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Hepatobiliary disorders Gallbladder Pain	0.00% 0/73 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	1.5% 1/67 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Infections and infestations Urinary Tract Infection	0.00% 0/73 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	1.5% 1/67 • Number of events 2 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Injury, poisoning and procedural complications Fall	4.1% 3/73 • Number of events 4 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	11.9% 8/67 • Number of events 8 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Musculoskeletal and connective tissue disorders Pain in Extremity	2.7% 2/73 • Number of events 2 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	1.5% 1/67 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Renal and urinary disorders Renal Calculi	0.00% 0/73 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	1.5% 1/67 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Respiratory, thoracic and mediastinal disorders Voice Alteration	0.00% 0/73 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	1.5% 1/67 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Skin and subcutaneous tissue disorders Skin Ulceration	0.00% 0/73 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	1.5% 1/67 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Vascular disorders Hypotension	1.4% 1/73 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	0.00% 0/67 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Nervous system disorders Cognitive Disturbance	1.4% 1/73 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	0.00% 0/67 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Nervous system disorders Dysarthria	1.4% 1/73 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	0.00% 0/67 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm - Salivary Gland	1.4% 1/73 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	0.00% 0/67 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm - Ovarian	1.4% 1/73 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	0.00% 0/67 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	2.7% 2/73 • Number of events 2 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	0.00% 0/67 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Infections and infestations Device Related Infection	1.4% 1/73 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	0.00% 0/67 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Gastrointestinal disorders Lower Gastrointestinal Bleeding	1.4% 1/73 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	0.00% 0/67 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.
Cardiac disorders Myocardial Infection	1.4% 1/73 • Number of events 1 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.	0.00% 0/67 • Information about adverse events were collected from active participants - either until they withdrew or completed the one-year study.