Trial Outcomes & Findings for Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Pediatric Protocol (NCT NCT04151199)
NCT ID: NCT04151199
Last Updated: 2026-07-14
Results Overview
Changes in log-transformed Cardiopulmonary Exercise Test (CPET) VO2 Peak calculated as L/min
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
318 participants
Primary outcome timeframe
Baseline; Week 12
Results posted on
2026-07-14
Participant Flow
Participant milestones
| Measure |
Only Cross Sectional HA
Did not participate in intervention after single acute exercise test of Endurance Exercise.
|
Only Cross Sectional LA
Did not participate in intervention after single acute exercise test of Endurance Exercise.
|
Endurance Exercise
Participants randomized to EE participated in the cross sectional phase and then in the intervention and completed the acute test and biospecimen collection following the intervention period.
|
No Intervention Control
The control group participated in the cross sectional phase and was randomized but did not participate in the intervention. Controls did complete the acute test and biospecimen collection following the intervention period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
114
|
100
|
39
|
|
Overall Study
COMPLETED
|
62
|
104
|
78
|
31
|
|
Overall Study
NOT COMPLETED
|
3
|
10
|
22
|
8
|
Reasons for withdrawal
| Measure |
Only Cross Sectional HA
Did not participate in intervention after single acute exercise test of Endurance Exercise.
|
Only Cross Sectional LA
Did not participate in intervention after single acute exercise test of Endurance Exercise.
|
Endurance Exercise
Participants randomized to EE participated in the cross sectional phase and then in the intervention and completed the acute test and biospecimen collection following the intervention period.
|
No Intervention Control
The control group participated in the cross sectional phase and was randomized but did not participate in the intervention. Controls did complete the acute test and biospecimen collection following the intervention period.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
9
|
13
|
7
|
|
Overall Study
Suspension due to COVID-19
|
1
|
1
|
6
|
1
|
Baseline Characteristics
Missing Category: Unable to calculate PHV due to missing data
Baseline characteristics by cohort
| Measure |
Only Cross Sectional HA
n=65 Participants
Did not participate in intervention after single acute exercise test of Endurance Exercise.
|
Only Cross Sectional LA
n=114 Participants
Did not participate in intervention after single acute exercise test of Endurance Exercise.
|
Endurance Exercise
n=100 Participants
Participants randomized to EE participated in the cross sectional phase and then in the intervention and completed the acute test and biospecimen collection following the intervention period.
|
No Intervention Control
n=39 Participants
The control group participated in the cross sectional phase and was randomized but did not participate in the intervention. Controls did complete the acute test and biospecimen collection following the intervention period.
|
Total
n=318 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=65 Participants
|
28 Participants
n=114 Participants
|
26 Participants
n=100 Participants
|
15 Participants
n=39 Participants
|
79 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=65 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=318 Participants
|
|
Age, Continuous
|
14 Years
STANDARD_DEVIATION 2 • n=65 Participants
|
13 Years
STANDARD_DEVIATION 2 • n=114 Participants
|
14 Years
STANDARD_DEVIATION 2 • n=100 Participants
|
14 Years
STANDARD_DEVIATION 2 • n=39 Participants
|
14 Years
STANDARD_DEVIATION 2 • n=318 Participants
|
|
Age, Customized
Age group · 10-13 years
|
27 Participants
n=65 Participants
|
61 Participants
n=114 Participants
|
47 Participants
n=100 Participants
|
14 Participants
n=39 Participants
|
149 Participants
n=318 Participants
|
|
Age, Customized
Age group · 14+ years
|
38 Participants
n=65 Participants
|
53 Participants
n=114 Participants
|
53 Participants
n=100 Participants
|
25 Participants
n=39 Participants
|
169 Participants
n=318 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=65 Participants
|
75 Participants
n=114 Participants
|
57 Participants
n=100 Participants
|
22 Participants
n=39 Participants
|
185 Participants
n=318 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=65 Participants
|
39 Participants
n=114 Participants
|
43 Participants
n=100 Participants
|
17 Participants
n=39 Participants
|
133 Participants
n=318 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=65 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=65 Participants
|
6 Participants
n=114 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=39 Participants
|
11 Participants
n=318 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=65 Participants
|
60 Participants
n=114 Participants
|
55 Participants
n=100 Participants
|
19 Participants
n=39 Participants
|
164 Participants
n=318 Participants
|
|
Race (NIH/OMB)
More than one race
|
21 Participants
n=65 Participants
|
16 Participants
n=114 Participants
|
19 Participants
n=100 Participants
|
4 Participants
n=39 Participants
|
60 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=65 Participants
|
2 Participants
n=114 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=39 Participants
|
2 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=65 Participants
|
29 Participants
n=114 Participants
|
37 Participants
n=100 Participants
|
6 Participants
n=39 Participants
|
79 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=65 Participants
|
85 Participants
n=114 Participants
|
63 Participants
n=100 Participants
|
33 Participants
n=39 Participants
|
239 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=65 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=318 Participants
|
|
Tanner Stage
1-2
|
22 Participants
n=65 Participants
|
33 Participants
n=114 Participants
|
25 Participants
n=100 Participants
|
7 Participants
n=39 Participants
|
87 Participants
n=318 Participants
|
|
Tanner Stage
3
|
8 Participants
n=65 Participants
|
10 Participants
n=114 Participants
|
12 Participants
n=100 Participants
|
11 Participants
n=39 Participants
|
41 Participants
n=318 Participants
|
|
Tanner Stage
4-5
|
35 Participants
n=65 Participants
|
71 Participants
n=114 Participants
|
63 Participants
n=100 Participants
|
21 Participants
n=39 Participants
|
190 Participants
n=318 Participants
|
|
Peak Height Velocity (PHV)
Post-peak height velocity
|
32 Participants
n=65 Participants • Missing Category: Unable to calculate PHV due to missing data
|
57 Participants
n=114 Participants • Missing Category: Unable to calculate PHV due to missing data
|
59 Participants
n=100 Participants • Missing Category: Unable to calculate PHV due to missing data
|
23 Participants
n=39 Participants • Missing Category: Unable to calculate PHV due to missing data
|
171 Participants
n=318 Participants • Missing Category: Unable to calculate PHV due to missing data
|
|
Peak Height Velocity (PHV)
Pre-peak height velocity
|
13 Participants
n=65 Participants • Missing Category: Unable to calculate PHV due to missing data
|
26 Participants
n=114 Participants • Missing Category: Unable to calculate PHV due to missing data
|
15 Participants
n=100 Participants • Missing Category: Unable to calculate PHV due to missing data
|
3 Participants
n=39 Participants • Missing Category: Unable to calculate PHV due to missing data
|
57 Participants
n=318 Participants • Missing Category: Unable to calculate PHV due to missing data
|
|
Peak Height Velocity (PHV)
Circa-peak height velocity
|
19 Participants
n=65 Participants • Missing Category: Unable to calculate PHV due to missing data
|
31 Participants
n=114 Participants • Missing Category: Unable to calculate PHV due to missing data
|
25 Participants
n=100 Participants • Missing Category: Unable to calculate PHV due to missing data
|
12 Participants
n=39 Participants • Missing Category: Unable to calculate PHV due to missing data
|
87 Participants
n=318 Participants • Missing Category: Unable to calculate PHV due to missing data
|
|
Peak Height Velocity (PHV)
Missing
|
1 Participants
n=65 Participants • Missing Category: Unable to calculate PHV due to missing data
|
0 Participants
n=114 Participants • Missing Category: Unable to calculate PHV due to missing data
|
1 Participants
n=100 Participants • Missing Category: Unable to calculate PHV due to missing data
|
1 Participants
n=39 Participants • Missing Category: Unable to calculate PHV due to missing data
|
3 Participants
n=318 Participants • Missing Category: Unable to calculate PHV due to missing data
|
|
Hemoglobin A1c (HbA1c)
|
5.2 Percentage of glcycosylated hemoglobin
STANDARD_DEVIATION 0.3 • n=62 Participants • There were 3 only cross-sectional HA participants and 11 only cross-sectional LA that did not have a baseline hemoglobin measure collected.
|
5.1 Percentage of glcycosylated hemoglobin
STANDARD_DEVIATION 0.4 • n=103 Participants • There were 3 only cross-sectional HA participants and 11 only cross-sectional LA that did not have a baseline hemoglobin measure collected.
|
5.1 Percentage of glcycosylated hemoglobin
STANDARD_DEVIATION 0.3 • n=100 Participants • There were 3 only cross-sectional HA participants and 11 only cross-sectional LA that did not have a baseline hemoglobin measure collected.
|
5.2 Percentage of glcycosylated hemoglobin
STANDARD_DEVIATION 0.4 • n=39 Participants • There were 3 only cross-sectional HA participants and 11 only cross-sectional LA that did not have a baseline hemoglobin measure collected.
|
5.2 Percentage of glcycosylated hemoglobin
STANDARD_DEVIATION 0.3 • n=304 Participants • There were 3 only cross-sectional HA participants and 11 only cross-sectional LA that did not have a baseline hemoglobin measure collected.
|
|
Triglycerides
|
65 mg/dl
STANDARD_DEVIATION 23 • n=65 Participants
|
79 mg/dl
STANDARD_DEVIATION 43 • n=114 Participants
|
79 mg/dl
STANDARD_DEVIATION 31 • n=100 Participants
|
71 mg/dl
STANDARD_DEVIATION 25 • n=39 Participants
|
75 mg/dl
STANDARD_DEVIATION 34 • n=318 Participants
|
|
High-Density Lipoprotein Cholesterol (HDL-C)
|
57 mg/dl
STANDARD_DEVIATION 12 • n=65 Participants
|
52 mg/dl
STANDARD_DEVIATION 11 • n=114 Participants
|
50 mg/dl
STANDARD_DEVIATION 11 • n=100 Participants
|
52 mg/dl
STANDARD_DEVIATION 9 • n=39 Participants
|
52 mg/dl
STANDARD_DEVIATION 11 • n=318 Participants
|
|
Low-Density Lipoprotein Cholesterol (LDL-C)
|
78 mg/dl
STANDARD_DEVIATION 19 • n=65 Participants
|
80 mg/dl
STANDARD_DEVIATION 21 • n=114 Participants
|
77 mg/dl
STANDARD_DEVIATION 23 • n=100 Participants
|
77 mg/dl
STANDARD_DEVIATION 19 • n=39 Participants
|
78 mg/dl
STANDARD_DEVIATION 21 • n=318 Participants
|
|
Absolute VO2 Peak
|
2.57 L/min
STANDARD_DEVIATION 0.80 • n=65 Participants
|
1.86 L/min
STANDARD_DEVIATION 0.45 • n=114 Participants
|
1.94 L/min
STANDARD_DEVIATION 0.48 • n=100 Participants
|
2.03 L/min
STANDARD_DEVIATION 0.48 • n=39 Participants
|
2.05 L/min
STANDARD_DEVIATION 0.61 • n=318 Participants
|
|
Relative VO2 Peak
|
50.7 ml/kg/min
STANDARD_DEVIATION 7.7 • n=65 Participants
|
36.5 ml/kg/min
STANDARD_DEVIATION 7.3 • n=114 Participants
|
36.9 ml/kg/min
STANDARD_DEVIATION 7.1 • n=100 Participants
|
36.1 ml/kg/min
STANDARD_DEVIATION 7.0 • n=39 Participants
|
39.4 ml/kg/min
STANDARD_DEVIATION 9.2 • n=318 Participants
|
|
Screening Height
|
160.9 cm
STANDARD_DEVIATION 13.2 • n=65 Participants
|
157.0 cm
STANDARD_DEVIATION 10.2 • n=114 Participants
|
160.5 cm
STANDARD_DEVIATION 11.5 • n=100 Participants
|
163.3 cm
STANDARD_DEVIATION 9.9 • n=39 Participants
|
159.7 cm
STANDARD_DEVIATION 11.4 • n=318 Participants
|
|
Screening Weight
|
50.7 kg
STANDARD_DEVIATION 12.9 • n=65 Participants
|
51.9 kg
STANDARD_DEVIATION 12.1 • n=114 Participants
|
53.6 kg
STANDARD_DEVIATION 12.4 • n=100 Participants
|
57.2 kg
STANDARD_DEVIATION 12.7 • n=39 Participants
|
52.9 kg
STANDARD_DEVIATION 12.5 • n=318 Participants
|
|
Body Mass Index Percentile
Low
|
63 Participants
n=65 Participants
|
86 Participants
n=114 Participants
|
81 Participants
n=100 Participants
|
31 Participants
n=39 Participants
|
261 Participants
n=318 Participants
|
|
Body Mass Index Percentile
High
|
2 Participants
n=65 Participants
|
28 Participants
n=114 Participants
|
19 Participants
n=100 Participants
|
8 Participants
n=39 Participants
|
57 Participants
n=318 Participants
|
|
Knee Extensor Strength
|
136.3 Newton meters
STANDARD_DEVIATION 52.0 • n=65 Participants
|
116.6 Newton meters
STANDARD_DEVIATION 38.6 • n=114 Participants
|
118.2 Newton meters
STANDARD_DEVIATION 37.1 • n=100 Participants
|
133.1 Newton meters
STANDARD_DEVIATION 39.1 • n=39 Participants
|
123.1 Newton meters
STANDARD_DEVIATION 41.9 • n=318 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 12Population: The Only Cross-Sectional HA and Only Cross-Sectional LA groups were only enrolled for baseline measures and do not have follow-up data or outcomes.
Changes in log-transformed Cardiopulmonary Exercise Test (CPET) VO2 Peak calculated as L/min
Outcome measures
| Measure |
Endurance Exercise
n=100 Participants
Participants randomized to EE participated in the cross sectional phase and then in the intervention and completed the acute test and biospecimen collection following the intervention period.
|
No Intervention Control
n=39 Participants
The control group participated in the cross sectional phase and was randomized but did not participate in the intervention. Controls did complete the acute test and biospecimen collection following the intervention period.
|
|---|---|---|
|
Cardiopulmonary Exercise Test (CPET) VO2 Peak
|
1.20 Ratio of geometric means
Interval 1.17 to 1.22
|
0.99 Ratio of geometric means
Interval 0.95 to 1.02
|
PRIMARY outcome
Timeframe: Baseline; Week 12Population: The Only Cross-Sectional HA and Only Cross-Sectional LA groups were only enrolled for baseline measures and do not have follow-up data or outcomes.
Changes in log-transformed knee extensor strength measured in newton meters
Outcome measures
| Measure |
Endurance Exercise
n=100 Participants
Participants randomized to EE participated in the cross sectional phase and then in the intervention and completed the acute test and biospecimen collection following the intervention period.
|
No Intervention Control
n=39 Participants
The control group participated in the cross sectional phase and was randomized but did not participate in the intervention. Controls did complete the acute test and biospecimen collection following the intervention period.
|
|---|---|---|
|
Knee Extensor Strength
|
1.06 Ratio of geometric means
Interval 1.03 to 1.09
|
1.04 Ratio of geometric means
Interval 1.0 to 1.09
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: The Only Cross-Sectional HA and Only Cross-Sectional LA groups were only enrolled for baseline measures and do not have follow-up data or outcomes.
Changes in log-transformed High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)
Outcome measures
| Measure |
Endurance Exercise
n=100 Participants
Participants randomized to EE participated in the cross sectional phase and then in the intervention and completed the acute test and biospecimen collection following the intervention period.
|
No Intervention Control
n=39 Participants
The control group participated in the cross sectional phase and was randomized but did not participate in the intervention. Controls did complete the acute test and biospecimen collection following the intervention period.
|
|---|---|---|
|
High-Density Lipoprotein Cholesterol (HDL-C)
|
1.04 Ratio of geometric means
Interval 1.01 to 1.07
|
1.02 Ratio of geometric means
Interval 0.98 to 1.06
|
SECONDARY outcome
Timeframe: Baseline; Week 12Changes in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)
Outcome measures
| Measure |
Endurance Exercise
n=100 Participants
Participants randomized to EE participated in the cross sectional phase and then in the intervention and completed the acute test and biospecimen collection following the intervention period.
|
No Intervention Control
n=39 Participants
The control group participated in the cross sectional phase and was randomized but did not participate in the intervention. Controls did complete the acute test and biospecimen collection following the intervention period.
|
|---|---|---|
|
Low-Density Lipoprotein Cholesterol (LDL-C)
|
-0.84 absolute difference in mg/dL
Interval -3.96 to 2.28
|
-1.12 absolute difference in mg/dL
Interval -5.6 to 3.36
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: The Only Cross-Sectional HA and Only Cross-Sectional LA groups were only enrolled for baseline measures and do not have follow-up data or outcomes.
Changes in log-transformed Triglycerides (mg/dL)
Outcome measures
| Measure |
Endurance Exercise
n=100 Participants
Participants randomized to EE participated in the cross sectional phase and then in the intervention and completed the acute test and biospecimen collection following the intervention period.
|
No Intervention Control
n=39 Participants
The control group participated in the cross sectional phase and was randomized but did not participate in the intervention. Controls did complete the acute test and biospecimen collection following the intervention period.
|
|---|---|---|
|
Triglycerides
|
1.00 Ratio of geometric means
Interval 0.93 to 1.07
|
0.94 Ratio of geometric means
Interval 0.85 to 1.03
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: The Only Cross-Sectional HA and Only Cross-Sectional LA groups were only enrolled for baseline measures and do not have follow-up data or outcomes.
Changes in Hemoglobin A1c (HbA1C) (%)
Outcome measures
| Measure |
Endurance Exercise
n=100 Participants
Participants randomized to EE participated in the cross sectional phase and then in the intervention and completed the acute test and biospecimen collection following the intervention period.
|
No Intervention Control
n=39 Participants
The control group participated in the cross sectional phase and was randomized but did not participate in the intervention. Controls did complete the acute test and biospecimen collection following the intervention period.
|
|---|---|---|
|
Hemoglobin A1c (HbA1C)
|
0.07 absolute difference in %
Interval 0.0 to 0.13
|
0.07 absolute difference in %
Interval -0.02 to 0.16
|
Adverse Events
Only Cross Sectional HA
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Only Cross Sectional LA
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Endurance Exercise
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
No Intervention Control
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Only Cross Sectional HA
n=65 participants at risk
Did not participate in intervention after single acute exercise test of Endurance Exercise.
|
Only Cross Sectional LA
n=114 participants at risk
Did not participate in intervention after single acute exercise test of Endurance Exercise.
|
Endurance Exercise
n=100 participants at risk
Participants randomized to EE participated in the cross sectional phase phase and then in the intervention and completed the acute test and biospecimen collection following the intervention period.
|
No Intervention Control
n=39 participants at risk
The control group participated in the cross sectional and was randomized but did not participate in the intervention. Controls did complete the acute test and biospecimen collection following the intervention period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.88%
1/114 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/100 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
1.0%
1/100 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/65 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
4.4%
5/114 • Number of events 5 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
12.0%
12/100 • Number of events 12 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
2.6%
1/39 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
2.0%
2/100 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
General disorders
Fatigue
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.88%
1/114 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
23.0%
23/100 • Number of events 41 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
2.6%
1/39 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
General disorders
Flu like symptoms
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
7.0%
7/100 • Number of events 7 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
2.6%
1/39 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
2.0%
2/100 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
1.0%
1/100 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.88%
1/114 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
7.0%
7/100 • Number of events 8 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
2.6%
1/39 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
1.0%
1/100 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
2.6%
1/39 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
1.0%
1/100 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
1.0%
1/100 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
1.0%
1/100 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
2.6%
1/39 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
1.0%
1/100 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
1.0%
1/100 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.88%
1/114 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
16.0%
16/100 • Number of events 33 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
3.0%
3/100 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Nervous system disorders
Headache
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
3.0%
3/100 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
2.6%
1/39 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.88%
1/114 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/100 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.88%
1/114 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/100 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
5.1%
2/39 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
2.6%
3/114 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
3.0%
3/100 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
1.0%
1/100 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
1.0%
1/100 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
1.0%
1/100 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
2.6%
3/114 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
2.0%
2/100 • Number of events 2 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
General disorders
Edema limbs
|
1.5%
1/65 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.88%
1/114 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/100 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
General disorders
Pain
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.88%
1/114 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
1.0%
1/100 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.88%
1/114 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/100 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
13.0%
13/100 • Number of events 19 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/114 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
25.0%
25/100 • Number of events 48 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
8.8%
10/114 • Number of events 10 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
6.0%
6/100 • Number of events 8 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
7.7%
3/39 • Number of events 5 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
6.1%
7/114 • Number of events 7 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
11.0%
11/100 • Number of events 14 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
10.3%
4/39 • Number of events 4 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/65 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
2.6%
3/114 • Number of events 3 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
1.0%
1/100 • Number of events 1 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
0.00%
0/39 • If a participant was consented and not enrolled/randomized then AEs were collected from time of consent until they were no longer participating in the study (~4-6 weeks depending on the screening visits). Once enrolled/randomized AEs were collected/reported for any reason until the end of study participation. For HA this was ~2-3 weeks (after the baseline testing) and for LA this was ~20 weeks (after baseline testing,12-wk intervention and post-intervention follow-up testing).
Expected AEs were collected systematically on CRFs at each assessment/session, unexpected AEs at those same visits were collected on AE logs. Non-systematic reporting of AEs were also collected on AE logs between visits.
|
Additional Information
Michael E. Miller
Wake Forest University School of Medicine
Phone: 336-716-6837
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place