Trial Outcomes & Findings for Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity (NCT NCT01814072)

NCT ID: NCT01814072

Last Updated: 2023-02-01

Results Overview

Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

562 participants

Primary outcome timeframe

From Baseline to Month 6

Results posted on

2023-02-01

Participant Flow

8593 were screened. 1159 attended orientation. 1078 signed consent. 562 were randomized.

Participants who signed an informed consent were invited to attend a baseline assessment where they were screened further for entry and exclusion criteria. Baseline data was gathered. Participants who continued to be eligible were scheduled for the randomization session where they learned their study assignment.

Participant milestones

Participant milestones
Measure
1. 12 Calls, PCP
Participant's received biweekly (12) coaching calls, and PCP Reports
2. 12 Calls, PCP, MR, Buddy
Participant's received biweekly (12) coaching calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training.
3. 12 Calls, PCP, Texts, Buddy
Participant received 12 calls, PCP Reports, Texts, and Buddy Training
4. 12 Calls, PCP, Texts, MR
Participant received 12 calls, PCP Reports, Texts, and Meal Replacement Recommendations
5. 12 Calls, Buddy
Participant received 12 calls, and Buddy Training
6. 12 Calls, MR
Participant received 12 calls, and Meal Replacement Recommendations
7. 12 Calls, Texts
Participant received 12 calls, and Texts
8. 12 Calls, Texts, MR, Buddy
Participant received 12 calls, Texts, Meal Replacement Recommendations, and Buddy Training
9. 24 Calls, PCP
Participants received 24 calls, and PCP Reports
10. 24 Calls, PCP, MR, Buddy
Participants received 24 calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training
11. 24 Calls, PCP, Texts, Buddy
Participants received 24 calls, PCP Reports, Texts, and Buddy Training
12. 24 Calls, PCP, Texts, MR
Participants received 24 calls, PCP Reports, Texts, and Meal Replacement Recommendations
13. 24 Calls, Buddy
Participants received 24 calls, and Buddy Training
14. 24 Calls, MR
Participants received 24 calls, and Meal Replacement Recommendations
15. 24 Calls, Texts
Participants received 24 calls, and Texts
16. 24 Calls, Texts, MR, Buddy
Participants received 24 calls, Texts, Meal Replacement Recommendations, and Buddy Training
17. 12 Calls
Participants received 12 calls
18. 12 Calls, MR, Buddy
Participants received 12 calls, Meal Replacement Recommendations, and Buddy Training
19. 12 Calls, Texts, Buddy
Participants received 12 calls, Texts, and Buddy Training
20. 12 Calls, Texts, MR
Participants received 12 calls, Texts, Meal Replacement Recommendations
21. 12 Calls, PCP, Buddy
Participants received 12 calls, PCP Reports, and Buddy Training
22. 12 Calls, PCP, MR
Participants received 12 calls, PCP Reports, and Meal Replacement Recommendations
23. 12 Calls PCP, Texts
Participants received 12 calls, PCP Reports, and Texts
24. 12 Calls, PCP, Texts, MR, Buddy
Participants received 12 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training
25. 24 Calls
Participants received 24 calls
26. 24 Calls, MR, Buddy
Participants received 24 calls, Meal Replacement Recommendations, and Buddy Training
27. 24 Calls, Texts, Buddy
Participants received 24 calls, Texts, and Buddy Training
28. 24 Calls, Texts, MR
Participants received 24 calls, Texts, and Meal Replacement Recommendations
29. 24 Calls, PCP, Buddy
Participants received 24 calls, PCP Reports, and Buddy Training
30. 24 Calls, PCP, MR
Participants received 24 calls, PCP Reports, and Meal Replacement Recommendations
31. 24 Calls, PCP, Texts
Participants received 24 calls, PCP Reports, and Texts
32. 24 Calls, PCP, Texts, MR, Buddy
Participants received 24 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training
Overall Study
STARTED
18
18
18
18
18
18
18
18
19
18
18
18
18
18
18
18
17
18
17
16
16
17
17
18
17
16
18
17
18
17
17
17
Overall Study
3-mo Visit
15
18
16
18
15
15
16
18
18
15
18
17
16
16
16
16
16
16
14
13
15
17
15
18
13
14
17
14
15
16
16
17
Overall Study
Intent to Treat
4
2
3
0
4
6
4
1
3
5
1
2
3
2
3
2
3
1
3
5
2
1
4
1
6
2
2
4
4
3
2
0
Overall Study
COMPLETED
14
16
15
18
14
12
14
17
16
13
17
16
15
16
15
16
14
17
14
11
14
16
13
17
11
14
16
13
14
14
15
17
Overall Study
NOT COMPLETED
4
2
3
0
4
6
4
1
3
5
1
2
3
2
3
2
3
1
3
5
2
1
4
1
6
2
2
4
4
3
2
0

Reasons for withdrawal

Reasons for withdrawal
Measure
1. 12 Calls, PCP
Participant's received biweekly (12) coaching calls, and PCP Reports
2. 12 Calls, PCP, MR, Buddy
Participant's received biweekly (12) coaching calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training.
3. 12 Calls, PCP, Texts, Buddy
Participant received 12 calls, PCP Reports, Texts, and Buddy Training
4. 12 Calls, PCP, Texts, MR
Participant received 12 calls, PCP Reports, Texts, and Meal Replacement Recommendations
5. 12 Calls, Buddy
Participant received 12 calls, and Buddy Training
6. 12 Calls, MR
Participant received 12 calls, and Meal Replacement Recommendations
7. 12 Calls, Texts
Participant received 12 calls, and Texts
8. 12 Calls, Texts, MR, Buddy
Participant received 12 calls, Texts, Meal Replacement Recommendations, and Buddy Training
9. 24 Calls, PCP
Participants received 24 calls, and PCP Reports
10. 24 Calls, PCP, MR, Buddy
Participants received 24 calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training
11. 24 Calls, PCP, Texts, Buddy
Participants received 24 calls, PCP Reports, Texts, and Buddy Training
12. 24 Calls, PCP, Texts, MR
Participants received 24 calls, PCP Reports, Texts, and Meal Replacement Recommendations
13. 24 Calls, Buddy
Participants received 24 calls, and Buddy Training
14. 24 Calls, MR
Participants received 24 calls, and Meal Replacement Recommendations
15. 24 Calls, Texts
Participants received 24 calls, and Texts
16. 24 Calls, Texts, MR, Buddy
Participants received 24 calls, Texts, Meal Replacement Recommendations, and Buddy Training
17. 12 Calls
Participants received 12 calls
18. 12 Calls, MR, Buddy
Participants received 12 calls, Meal Replacement Recommendations, and Buddy Training
19. 12 Calls, Texts, Buddy
Participants received 12 calls, Texts, and Buddy Training
20. 12 Calls, Texts, MR
Participants received 12 calls, Texts, Meal Replacement Recommendations
21. 12 Calls, PCP, Buddy
Participants received 12 calls, PCP Reports, and Buddy Training
22. 12 Calls, PCP, MR
Participants received 12 calls, PCP Reports, and Meal Replacement Recommendations
23. 12 Calls PCP, Texts
Participants received 12 calls, PCP Reports, and Texts
24. 12 Calls, PCP, Texts, MR, Buddy
Participants received 12 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training
25. 24 Calls
Participants received 24 calls
26. 24 Calls, MR, Buddy
Participants received 24 calls, Meal Replacement Recommendations, and Buddy Training
27. 24 Calls, Texts, Buddy
Participants received 24 calls, Texts, and Buddy Training
28. 24 Calls, Texts, MR
Participants received 24 calls, Texts, and Meal Replacement Recommendations
29. 24 Calls, PCP, Buddy
Participants received 24 calls, PCP Reports, and Buddy Training
30. 24 Calls, PCP, MR
Participants received 24 calls, PCP Reports, and Meal Replacement Recommendations
31. 24 Calls, PCP, Texts
Participants received 24 calls, PCP Reports, and Texts
32. 24 Calls, PCP, Texts, MR, Buddy
Participants received 24 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training
Overall Study
Lost to Follow-up
2
2
2
0
2
3
3
1
2
3
1
2
2
1
2
1
3
1
3
3
2
1
3
1
4
1
1
2
3
3
2
0
Overall Study
Withdrawal by Subject
2
0
1
0
2
3
1
0
1
2
0
0
1
1
1
1
0
0
0
2
0
0
1
0
2
1
1
2
1
0
0
0

Baseline Characteristics

Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
1. 12 Calls, PCP
n=18 Participants
Participants received biweekly (12) coaching calls, and PCP Reports
2. 12 Calls, PCP, MR, Buddy
n=18 Participants
Participants received biweekly (12) coaching calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training.
3. 12 Calls, PCP, Texts, Buddy
n=18 Participants
Participants received 12 calls, PCP Reports, Texts, and Buddy Training
4. 12 Calls, PCP, Texts, MR
n=18 Participants
Participants received 12 calls, PCP Reports, Texts, and Meal Replacement Recommendations
5. 12 Calls, Buddy
n=18 Participants
Participants received 12 calls, and Buddy Training
6. 12 Calls, MR
n=18 Participants
Participants received 12 calls, and Meal Replacement Recommendations
7. 12 Calls, Texts
n=18 Participants
Participants received 12 calls, and Texts
8. 12 Calls, Texts, MR, Buddy
n=18 Participants
Participants received 12 calls, Texts, Meal Replacement Recommendations, and Buddy Training
9. 24 Calls, PCP
n=19 Participants
Participants received 24 calls, and PCP Reports
10. 24 Calls, PCP, MR, Buddy
n=18 Participants
Participants received 24 calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training
11. 24 Calls, PCP, Texts, Buddy
n=18 Participants
Participants received 24 calls, PCP Reports, Texts, and Buddy Training
12. 24 Calls, PCP, Texts, MR
n=18 Participants
Participants received 24 calls, PCP Reports, Texts, and Meal Replacement Recommendations
13. 24 Calls, Buddy
n=18 Participants
Participants received 24 calls, and Buddy Training
14. 24 Calls, MR
n=18 Participants
Participants received 24 calls, and Meal Replacement Recommendations
15. 24 Calls, Texts
n=18 Participants
Participants received 24 calls, and Texts
16. 24 Calls, Texts, MR, Buddy
n=18 Participants
Participants received 24 calls, Texts, Meal Replacement Recommendations, and Buddy Training
17. 12 Calls
n=17 Participants
Participants received 12 calls
18. 12 Calls, MR, Buddy
n=18 Participants
Participants received 12 calls, Meal Replacement Recommendations, and Buddy Training
19. 12 Calls, Texts, Buddy
n=17 Participants
Participants received 12 calls, Texts, and Buddy Training
20. 12 Calls, Texts, MR
n=16 Participants
Participants received 12 calls, Texts, Meal Replacement Recommendations
21. 12 Calls, PCP, Buddy
n=16 Participants
Participants received 12 calls, PCP Reports, and Buddy Training
22. 12 Calls, PCP, MR
n=17 Participants
Participants received 12 calls, PCP Reports, and Meal Replacement Recommendations
23. 12 Calls PCP, Texts
n=17 Participants
Participants received 12 calls, PCP Reports, and Texts
24. 12 Calls, PCP, Texts, MR, Buddy
n=18 Participants
Participants received 12 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training
25. 24 Calls
n=17 Participants
Participants received 24 calls
26. 24 Calls, MR, Buddy
n=16 Participants
Participants received 24 calls, Meal Replacement Recommendations, and Buddy Training
27. 24 Calls, Texts, Buddy
n=18 Participants
Participants received 24 calls, Texts, and Buddy Training
28. 24 Calls, Texts, MR
n=17 Participants
Participants received 24 calls, Texts, and Meal Replacement Recommendations
29. 24 Calls, PCP, Buddy
n=18 Participants
Participants received 24 calls, PCP Reports, and Buddy Training
30. 24 Calls, PCP, MR
n=17 Participants
Participants received 24 calls, PCP Reports, and Meal Replacement Recommendations
31. 24 Calls, PCP, Texts
n=17 Participants
Participants received 24 calls, PCP Reports, and Texts
32. 24 Calls, PCP, Texts, MR, Buddy
n=17 Participants
Participants received 24 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training
Total
n=562 Participants
Total of all reporting groups
Age, Continuous
40.0 years
STANDARD_DEVIATION 8.6 • n=5 Participants
43.2 years
STANDARD_DEVIATION 14.2 • n=7 Participants
41.7 years
STANDARD_DEVIATION 10.9 • n=5 Participants
40.2 years
STANDARD_DEVIATION 11.2 • n=4 Participants
31.4 years
STANDARD_DEVIATION 9.1 • n=21 Participants
40.5 years
STANDARD_DEVIATION 9.9 • n=8 Participants
40.8 years
STANDARD_DEVIATION 12.2 • n=8 Participants
39.4 years
STANDARD_DEVIATION 12.9 • n=24 Participants
39.5 years
STANDARD_DEVIATION 8.3 • n=42 Participants
38.7 years
STANDARD_DEVIATION 8.9 • n=42 Participants
39.1 years
STANDARD_DEVIATION 11.2 • n=42 Participants
40.6 years
STANDARD_DEVIATION 12.0 • n=42 Participants
40.4 years
STANDARD_DEVIATION 9.1 • n=36 Participants
36.3 years
STANDARD_DEVIATION 10.6 • n=36 Participants
39.8 years
STANDARD_DEVIATION 12.8 • n=24 Participants
35.8 years
STANDARD_DEVIATION 11.8 • n=135 Participants
38.2 years
STANDARD_DEVIATION 12.0 • n=136 Participants
39.2 years
STANDARD_DEVIATION 10.5 • n=44 Participants
37.4 years
STANDARD_DEVIATION 10.9 • n=667 Participants
32.2 years
STANDARD_DEVIATION 7.1 • n=12 Participants
36.7 years
STANDARD_DEVIATION 6.0 • n=12 Participants
40.3 years
STANDARD_DEVIATION 10.8 • n=12 Participants
40.1 years
STANDARD_DEVIATION 11.6 • n=12 Participants
37.9 years
STANDARD_DEVIATION 12.8 • n=11 Participants
35.7 years
STANDARD_DEVIATION 9.6 • n=6 Participants
47.3 years
STANDARD_DEVIATION 10.2 • n=7 Participants
35.1 years
STANDARD_DEVIATION 9.0 • n=7 Participants
41.0 years
STANDARD_DEVIATION 10.1 • n=408 Participants
39.1 years
STANDARD_DEVIATION 11.7 • n=206 Participants
37.2 years
STANDARD_DEVIATION 9.9 • n=16 Participants
40.6 years
STANDARD_DEVIATION 12.8 • n=252 Participants
39.9 years
STANDARD_DEVIATION 12.0 • n=8 Participants
38.9 years
STANDARD_DEVIATION 10.9 • n=269 Participants
Sex: Female, Male
Female
15 Participants
n=5 Participants
15 Participants
n=7 Participants
15 Participants
n=5 Participants
15 Participants
n=4 Participants
15 Participants
n=21 Participants
15 Participants
n=8 Participants
15 Participants
n=8 Participants
15 Participants
n=24 Participants
16 Participants
n=42 Participants
15 Participants
n=42 Participants
15 Participants
n=42 Participants
15 Participants
n=42 Participants
15 Participants
n=36 Participants
15 Participants
n=36 Participants
15 Participants
n=24 Participants
15 Participants
n=135 Participants
14 Participants
n=136 Participants
14 Participants
n=44 Participants
14 Participants
n=667 Participants
12 Participants
n=12 Participants
13 Participants
n=12 Participants
14 Participants
n=12 Participants
14 Participants
n=12 Participants
14 Participants
n=11 Participants
14 Participants
n=6 Participants
13 Participants
n=7 Participants
14 Participants
n=7 Participants
14 Participants
n=408 Participants
14 Participants
n=206 Participants
14 Participants
n=16 Participants
13 Participants
n=252 Participants
13 Participants
n=8 Participants
459 Participants
n=269 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
3 Participants
n=4 Participants
3 Participants
n=21 Participants
3 Participants
n=8 Participants
3 Participants
n=8 Participants
3 Participants
n=24 Participants
3 Participants
n=42 Participants
3 Participants
n=42 Participants
3 Participants
n=42 Participants
3 Participants
n=42 Participants
3 Participants
n=36 Participants
3 Participants
n=36 Participants
3 Participants
n=24 Participants
3 Participants
n=135 Participants
3 Participants
n=136 Participants
4 Participants
n=44 Participants
3 Participants
n=667 Participants
4 Participants
n=12 Participants
3 Participants
n=12 Participants
3 Participants
n=12 Participants
3 Participants
n=12 Participants
4 Participants
n=11 Participants
3 Participants
n=6 Participants
3 Participants
n=7 Participants
4 Participants
n=7 Participants
3 Participants
n=408 Participants
4 Participants
n=206 Participants
3 Participants
n=16 Participants
4 Participants
n=252 Participants
4 Participants
n=8 Participants
103 Participants
n=269 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants
n=5 Participants
18 Participants
n=7 Participants
16 Participants
n=5 Participants
11 Participants
n=4 Participants
15 Participants
n=21 Participants
18 Participants
n=8 Participants
16 Participants
n=8 Participants
13 Participants
n=24 Participants
16 Participants
n=42 Participants
16 Participants
n=42 Participants
18 Participants
n=42 Participants
17 Participants
n=42 Participants
13 Participants
n=36 Participants
17 Participants
n=36 Participants
17 Participants
n=24 Participants
17 Participants
n=135 Participants
13 Participants
n=136 Participants
16 Participants
n=44 Participants
12 Participants
n=667 Participants
14 Participants
n=12 Participants
13 Participants
n=12 Participants
14 Participants
n=12 Participants
15 Participants
n=12 Participants
16 Participants
n=11 Participants
15 Participants
n=6 Participants
16 Participants
n=7 Participants
18 Participants
n=7 Participants
14 Participants
n=408 Participants
16 Participants
n=206 Participants
15 Participants
n=16 Participants
15 Participants
n=252 Participants
17 Participants
n=8 Participants
489 Participants
n=269 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
4 Participants
n=4 Participants
3 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
2 Participants
n=24 Participants
3 Participants
n=42 Participants
2 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
4 Participants
n=36 Participants
1 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
4 Participants
n=136 Participants
2 Participants
n=44 Participants
3 Participants
n=667 Participants
2 Participants
n=12 Participants
2 Participants
n=12 Participants
1 Participants
n=12 Participants
2 Participants
n=12 Participants
2 Participants
n=11 Participants
2 Participants
n=6 Participants
0 Participants
n=7 Participants
0 Participants
n=7 Participants
2 Participants
n=408 Participants
2 Participants
n=206 Participants
2 Participants
n=16 Participants
1 Participants
n=252 Participants
0 Participants
n=8 Participants
53 Participants
n=269 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
3 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=36 Participants
0 Participants
n=36 Participants
1 Participants
n=24 Participants
1 Participants
n=135 Participants
0 Participants
n=136 Participants
0 Participants
n=44 Participants
2 Participants
n=667 Participants
0 Participants
n=12 Participants
1 Participants
n=12 Participants
2 Participants
n=12 Participants
0 Participants
n=12 Participants
0 Participants
n=11 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
0 Participants
n=7 Participants
1 Participants
n=408 Participants
0 Participants
n=206 Participants
0 Participants
n=16 Participants
1 Participants
n=252 Participants
0 Participants
n=8 Participants
20 Participants
n=269 Participants
Race/Ethnicity, Customized
White/Caucasian
10 Participants
n=5 Participants
15 Participants
n=7 Participants
11 Participants
n=5 Participants
12 Participants
n=4 Participants
16 Participants
n=21 Participants
15 Participants
n=8 Participants
15 Participants
n=8 Participants
10 Participants
n=24 Participants
15 Participants
n=42 Participants
14 Participants
n=42 Participants
14 Participants
n=42 Participants
12 Participants
n=42 Participants
12 Participants
n=36 Participants
15 Participants
n=36 Participants
15 Participants
n=24 Participants
14 Participants
n=135 Participants
13 Participants
n=136 Participants
15 Participants
n=44 Participants
9 Participants
n=667 Participants
14 Participants
n=12 Participants
11 Participants
n=12 Participants
14 Participants
n=12 Participants
12 Participants
n=12 Participants
14 Participants
n=11 Participants
12 Participants
n=6 Participants
13 Participants
n=7 Participants
14 Participants
n=7 Participants
9 Participants
n=408 Participants
13 Participants
n=206 Participants
10 Participants
n=16 Participants
13 Participants
n=252 Participants
16 Participants
n=8 Participants
417 Participants
n=269 Participants
Race/Ethnicity, Customized
Black
3 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
3 Participants
n=4 Participants
2 Participants
n=21 Participants
2 Participants
n=8 Participants
1 Participants
n=8 Participants
5 Participants
n=24 Participants
4 Participants
n=42 Participants
3 Participants
n=42 Participants
4 Participants
n=42 Participants
4 Participants
n=42 Participants
5 Participants
n=36 Participants
2 Participants
n=36 Participants
3 Participants
n=24 Participants
3 Participants
n=135 Participants
1 Participants
n=136 Participants
2 Participants
n=44 Participants
3 Participants
n=667 Participants
1 Participants
n=12 Participants
2 Participants
n=12 Participants
1 Participants
n=12 Participants
4 Participants
n=12 Participants
3 Participants
n=11 Participants
1 Participants
n=6 Participants
1 Participants
n=7 Participants
3 Participants
n=7 Participants
5 Participants
n=408 Participants
4 Participants
n=206 Participants
2 Participants
n=16 Participants
2 Participants
n=252 Participants
1 Participants
n=8 Participants
87 Participants
n=269 Participants
Race/Ethnicity, Customized
Asian
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
1 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
1 Participants
n=135 Participants
0 Participants
n=136 Participants
0 Participants
n=44 Participants
2 Participants
n=667 Participants
0 Participants
n=12 Participants
1 Participants
n=12 Participants
0 Participants
n=12 Participants
0 Participants
n=12 Participants
0 Participants
n=11 Participants
2 Participants
n=6 Participants
1 Participants
n=7 Participants
0 Participants
n=7 Participants
0 Participants
n=408 Participants
0 Participants
n=206 Participants
0 Participants
n=16 Participants
1 Participants
n=252 Participants
0 Participants
n=8 Participants
16 Participants
n=269 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
2 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
0 Participants
n=44 Participants
0 Participants
n=667 Participants
0 Participants
n=12 Participants
0 Participants
n=12 Participants
0 Participants
n=12 Participants
0 Participants
n=12 Participants
0 Participants
n=11 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
0 Participants
n=7 Participants
2 Participants
n=408 Participants
0 Participants
n=206 Participants
0 Participants
n=16 Participants
0 Participants
n=252 Participants
0 Participants
n=8 Participants
5 Participants
n=269 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
1 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
0 Participants
n=44 Participants
0 Participants
n=667 Participants
0 Participants
n=12 Participants
0 Participants
n=12 Participants
0 Participants
n=12 Participants
0 Participants
n=12 Participants
0 Participants
n=11 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
0 Participants
n=7 Participants
0 Participants
n=408 Participants
0 Participants
n=206 Participants
0 Participants
n=16 Participants
0 Participants
n=252 Participants
0 Participants
n=8 Participants
1 Participants
n=269 Participants
Race/Ethnicity, Customized
Other/Unknown
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
3 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
3 Participants
n=136 Participants
1 Participants
n=44 Participants
3 Participants
n=667 Participants
1 Participants
n=12 Participants
2 Participants
n=12 Participants
2 Participants
n=12 Participants
1 Participants
n=12 Participants
1 Participants
n=11 Participants
2 Participants
n=6 Participants
1 Participants
n=7 Participants
1 Participants
n=7 Participants
1 Participants
n=408 Participants
1 Participants
n=206 Participants
5 Participants
n=16 Participants
1 Participants
n=252 Participants
0 Participants
n=8 Participants
36 Participants
n=269 Participants
Weight (kg)
88.9 Kilograms
STANDARD_DEVIATION 10.6 • n=5 Participants
91.2 Kilograms
STANDARD_DEVIATION 14.0 • n=7 Participants
87.3 Kilograms
STANDARD_DEVIATION 12.0 • n=5 Participants
88.8 Kilograms
STANDARD_DEVIATION 14.0 • n=4 Participants
90.4 Kilograms
STANDARD_DEVIATION 11.3 • n=21 Participants
90.0 Kilograms
STANDARD_DEVIATION 13.3 • n=8 Participants
97.8 Kilograms
STANDARD_DEVIATION 13.3 • n=8 Participants
87.3 Kilograms
STANDARD_DEVIATION 13.4 • n=24 Participants
94.4 Kilograms
STANDARD_DEVIATION 14.7 • n=42 Participants
93.1 Kilograms
STANDARD_DEVIATION 12.9 • n=42 Participants
97.6 Kilograms
STANDARD_DEVIATION 14.4 • n=42 Participants
88.1 Kilograms
STANDARD_DEVIATION 13.4 • n=42 Participants
89.6 Kilograms
STANDARD_DEVIATION 12.9 • n=36 Participants
87.2 Kilograms
STANDARD_DEVIATION 13.9 • n=36 Participants
94.3 Kilograms
STANDARD_DEVIATION 14.7 • n=24 Participants
91.3 Kilograms
STANDARD_DEVIATION 11.3 • n=135 Participants
88.4 Kilograms
STANDARD_DEVIATION 13.7 • n=136 Participants
90.2 Kilograms
STANDARD_DEVIATION 15.2 • n=44 Participants
90.8 Kilograms
STANDARD_DEVIATION 14.8 • n=667 Participants
83.3 Kilograms
STANDARD_DEVIATION 9.8 • n=12 Participants
92.9 Kilograms
STANDARD_DEVIATION 14.8 • n=12 Participants
86.1 Kilograms
STANDARD_DEVIATION 10.5 • n=12 Participants
98.0 Kilograms
STANDARD_DEVIATION 15.3 • n=12 Participants
90.5 Kilograms
STANDARD_DEVIATION 17.6 • n=11 Participants
80.7 Kilograms
STANDARD_DEVIATION 12.2 • n=6 Participants
89.8 Kilograms
STANDARD_DEVIATION 9.9 • n=7 Participants
90.1 Kilograms
STANDARD_DEVIATION 12.0 • n=7 Participants
85.5 Kilograms
STANDARD_DEVIATION 10.8 • n=408 Participants
89.7 Kilograms
STANDARD_DEVIATION 13.4 • n=206 Participants
93.7 Kilograms
STANDARD_DEVIATION 16.6 • n=16 Participants
86.8 Kilograms
STANDARD_DEVIATION 11.5 • n=252 Participants
86.1 Kilograms
STANDARD_DEVIATION 16.0 • n=8 Participants
90.0 Kilograms
STANDARD_DEVIATION 13.6 • n=269 Participants

PRIMARY outcome

Timeframe: From Baseline to Month 6

Population: ITT population: all randomized participants with at least one weight value. The decision to analyze all randomized participants together for aim 1, rather than separately by arm, was pre-specified in the the Protocol/Statistical Analysis Plan for the purposes of assessing the main effect of time.

Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).

Outcome measures

Outcome measures
Measure
All Reporting Groups
n=562 Participants
All participants regardless of individual randomly assigned combination of On- or Off switched levels of all intervention factors, weight measured at baseline and at Month 6.
PCP Reports
Participant's primary care physician was (On) or was not (Off) sent a progress report after the 3 and 6 month assessments.
Text Messages
Participants either received (On) or did not receive (Off) push notifications through the app at their preferred time or when they opened the app.
Meal Replacements
Participants either received (On) or did not receive (Off) a one week supply of meal replacement bars and shakes. Those who did receive a 1-week supply of meal replacements were provided with recommendations on each coaching call to continue using these products throughout the intervention.
Buddy Training
Participant buddies either received (On) or did not receive (Off) additional training.
Weight Change (kg) From Baseline to Month 6, Main Effect of Time
-4.8 Kg
Interval -5.3 to -4.4

PRIMARY outcome

Timeframe: From Baseline to Month 6

Population: ITT population: all randomized participants with at least one weight value.

Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as an additional effect beyond that of Outcome Measure 1 (each component has it's own weight loss effect that is above and beyond the weight change calculated in the Outcome Measure 1 analyses).

Outcome measures

Outcome measures
Measure
All Reporting Groups
n=562 Participants
All participants regardless of individual randomly assigned combination of On- or Off switched levels of all intervention factors, weight measured at baseline and at Month 6.
PCP Reports
n=562 Participants
Participant's primary care physician was (On) or was not (Off) sent a progress report after the 3 and 6 month assessments.
Text Messages
n=562 Participants
Participants either received (On) or did not receive (Off) push notifications through the app at their preferred time or when they opened the app.
Meal Replacements
n=562 Participants
Participants either received (On) or did not receive (Off) a one week supply of meal replacement bars and shakes. Those who did receive a 1-week supply of meal replacements were provided with recommendations on each coaching call to continue using these products throughout the intervention.
Buddy Training
n=562 Participants
Participant buddies either received (On) or did not receive (Off) additional training.
Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction
.1244 Kg
Interval -0.3026 to 0.5513
-.0226 Kg
Interval -0.4495 to 0.4044
.0840 Kg
Interval -0.3429 to 0.5109
.1081 Kg
Interval -0.3188 to 0.535
-.4353 Kg
Interval -0.8622 to -0.0084

SECONDARY outcome

Timeframe: 6 months

Population: ITT population: weight loss data from all randomized participants with at least one weight value; combined with cost data for study implementation (staff time, supplies, etc.)

Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.

Outcome measures

Outcome measures
Measure
All Reporting Groups
n=562 Participants
All participants regardless of individual randomly assigned combination of On- or Off switched levels of all intervention factors, weight measured at baseline and at Month 6.
PCP Reports
Participant's primary care physician was (On) or was not (Off) sent a progress report after the 3 and 6 month assessments.
Text Messages
Participants either received (On) or did not receive (Off) push notifications through the app at their preferred time or when they opened the app.
Meal Replacements
Participants either received (On) or did not receive (Off) a one week supply of meal replacement bars and shakes. Those who did receive a 1-week supply of meal replacements were provided with recommendations on each coaching call to continue using these products throughout the intervention.
Buddy Training
Participant buddies either received (On) or did not receive (Off) additional training.
Intervention for <$500
427 dollars

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Treatment adherence is a hypothesized mediator that will be operationalized as the number of treatment sessions completed divided by the number of treatment sessions offered (12 or 24)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Self-monitoring is a hypothesized mediator that will be operationalized as the number of days recording weight, dietary intake, and physical activity

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Self-efficacy is an exploratory mediator that will be assessed to examine treatment effects on confidence about performing two categories of behaviors associated with weight loss: diet and physical activity

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Self-regulation is an exploratory mediator that will be assessed using the Three Factor Eating Questionnaire and Treatment Self-Regulation Questionnaire

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Supportive accountability is an exploratory mediator that will be measured by assessing two constructs that define supportive accountability: therapeutic alliance and perceived autonomy support

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Facilitation is an exploratory mediator that will be measured by rating how much the tools provided by the study have changed their environment and by the Weight Management Support Inventory

Outcome measures

Outcome data not reported

Adverse Events

Condition 16

Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths

Condition 17

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Condition 18

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Condition 19

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Condition 20

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Condition 21

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Condition 22

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Condition 23

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Condition 24

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Condition 25

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Condition 26

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Condition 27

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Condition 28

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Condition 29

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Condition 30

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Condition 31

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Condition 32

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Condition 1

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Condition 2

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Condition 3

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Condition 4

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Condition 5

Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths

Condition 6

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Condition 7

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Condition 8

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Condition 9

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Condition 10

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Condition 11

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Condition 12

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Condition 13

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Condition 14

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Condition 15

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Condition 16
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 17
n=17 participants at risk
1\) Lifestyle Core; 2) 12 Telephone Coaching Sessions 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions
Condition 18
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 19
n=17 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Text Messages: Participants will receive regular text messages Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 20
n=16 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Condition 21
n=16 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 22
n=17 participants at risk
1\) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician
Condition 23
n=17 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages
Condition 24
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 25
n=17 participants at risk
1\) Lifestyle Core; 2) 24 telephone coaching sessions 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions
Condition 26
n=16 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 27
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Text Messages: Participants will receive regular text messages Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 28
n=17 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Condition 29
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 30
n=17 participants at risk
1\) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Condition 31
n=17 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages
Condition 32
n=17 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 1
n=18 participants at risk
1\) Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician
Condition 2
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 3
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 4
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Condition 5
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 6
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Condition 7
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Text Messages: Participants will receive regular text messages
Condition 8
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 9
n=18 participants at risk;n=19 participants at risk
1\) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician
Condition 10
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 11
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 12
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Condition 13
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 14
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Condition 15
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Text Messages: Participants will receive regular text messages
Injury, poisoning and procedural complications
severe head injury
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/19 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Injury, poisoning and procedural complications
Brain bleed
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/19 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.

Other adverse events

Other adverse events
Measure
Condition 16
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 17
n=17 participants at risk
1\) Lifestyle Core; 2) 12 Telephone Coaching Sessions 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions
Condition 18
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 19
n=17 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Text Messages: Participants will receive regular text messages Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 20
n=16 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Condition 21
n=16 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 22
n=17 participants at risk
1\) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician
Condition 23
n=17 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages
Condition 24
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 25
n=17 participants at risk
1\) Lifestyle Core; 2) 24 telephone coaching sessions 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions
Condition 26
n=16 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 27
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Text Messages: Participants will receive regular text messages Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 28
n=17 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Condition 29
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 30
n=17 participants at risk
1\) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Condition 31
n=17 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages
Condition 32
n=17 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 1
n=18 participants at risk
1\) Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician
Condition 2
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 3
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 4
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Condition 5
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 6
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Condition 7
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Text Messages: Participants will receive regular text messages
Condition 8
n=18 participants at risk
1\) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars 12 Telephone Coaching Sessions: Participants will receive 12 telephone coaching sessions Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 9
n=18 participants at risk;n=19 participants at risk
1\) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician
Condition 10
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 11
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 12
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Report to Primary Care Physician: Participants will have a report detailing their weight loss progress sent to their primary care physician Text Messages: Participants will receive regular text messages Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Condition 13
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Buddy Training: Participants will have a buddy that will be trained via webinars to be a supportive buddy
Condition 14
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Recommendations to use meal replacements: Participants will receive recommendations from their coach to use meal replacements
Condition 15
n=18 participants at risk
1\) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages 24 Telephone Coaching Sessions: Participants will receive 24 telephone coaching sessions Text Messages: Participants will receive regular text messages
Infections and infestations
urinary tract infection
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Injury, poisoning and procedural complications
blisters
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Infections and infestations
mononucleosis
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Product Issues
intolerance to meal replacements
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Psychiatric disorders
eating disorder
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Endocrine disorders
thyroid imbalance
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Endocrine disorders
thyroid cancer
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Eye disorders
anterior scleritis
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Gastrointestinal disorders
stomach ache
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Gastrointestinal disorders
stomach ulcer
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Gastrointestinal disorders
constipation
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Gastrointestinal disorders
colitis
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
General disorders
medication switch
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
General disorders
bicycle accident
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Immune system disorders
neutropenia
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Infections and infestations
influenza
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Infections and infestations
food poisoning
11.1%
2/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
16.7%
3/18 • Number of events 3 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Infections and infestations
sinus infection
16.7%
3/18 • Number of events 4 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Infections and infestations
strep throat
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Infections and infestations
common cold
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Infections and infestations
bronchitis
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
6.2%
1/16 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
11.1%
2/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Infections and infestations
pneumonia
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Infections and infestations
stomach flu
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Infections and infestations
staph infection
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Infections and infestations
general respiratory infection
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Infections and infestations
ear infection
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Psychiatric disorders
depression
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
6.2%
1/16 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Renal and urinary disorders
bladder cancer
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Skin and subcutaneous tissue disorders
skin cancer
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Nervous system disorders
epilepsy
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Nervous system disorders
pinched nerve
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Nervous system disorders
seizure disorder
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Nervous system disorders
spinal stenosis
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Respiratory, thoracic and mediastinal disorders
asthma
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Reproductive system and breast disorders
polycystic ovary syndrome
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Reproductive system and breast disorders
abnormal mammogram
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Reproductive system and breast disorders
uterine prolapse
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Reproductive system and breast disorders
breast cancer
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Musculoskeletal and connective tissue disorders
osteoarthritis
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Musculoskeletal and connective tissue disorders
tendonitis
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Musculoskeletal and connective tissue disorders
plantar fasciitis
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Musculoskeletal and connective tissue disorders
degenerative disc disease
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Musculoskeletal and connective tissue disorders
arthritis
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Musculoskeletal and connective tissue disorders
capsulitis
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
6.2%
1/16 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Surgical and medical procedures
dental procedure
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
11.1%
2/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Surgical and medical procedures
skin surgery
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Surgical and medical procedures
foot surgery
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Surgical and medical procedures
hyperhidrosis surgery
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Surgical and medical procedures
stomach surgery
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Surgical and medical procedures
elbow surgery
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Surgical and medical procedures
kidney stone surgery
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Surgical and medical procedures
lasik eye surgery
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Injury, poisoning and procedural complications
muscle soreness
11.1%
2/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
6.2%
1/16 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
11.1%
2/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
16.7%
3/18 • Number of events 4 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Injury, poisoning and procedural complications
joint soreness
16.7%
3/18 • Number of events 3 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
6.2%
1/16 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
11.1%
2/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
11.1%
2/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Injury, poisoning and procedural complications
muscle strain
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
11.1%
2/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
11.1%
2/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Injury, poisoning and procedural complications
ankle sprain
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
11.1%
2/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Injury, poisoning and procedural complications
fracture
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
6.2%
1/16 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Injury, poisoning and procedural complications
contusion
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Injury, poisoning and procedural complications
laceration
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
11.1%
2/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Injury, poisoning and procedural complications
migraine
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
11.1%
2/18 • Number of events 3 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Injury, poisoning and procedural complications
muscle cramps
5.6%
1/18 • Number of events 2 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.9%
1/17 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Injury, poisoning and procedural complications
knee sprain
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
Injury, poisoning and procedural complications
mild concussion
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/16 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/17 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
5.6%
1/18 • Number of events 1 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.
0.00%
0/18 • Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.

Additional Information

Bonnie Spring, PhD, ABPP

Northwestern University Feinberg School of Medicine

Phone: 312-908-2293

Results disclosure agreements

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