Trial Outcomes & Findings for Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES) (NCT NCT01302080)

NCT ID: NCT01302080

Last Updated: 2021-10-14

Results Overview

Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

• Recruitment status: COMPLETED
• Target enrollment: 941 participants
• Primary outcome timeframe: Baseline, Month 3
• Results posted on: 2021-10-14

Participant Flow

This was a non-interventional observational study. Participants to be enrolled were of age 6 to 16 (inclusive), exposed to sertraline (with or without psychotherapy) and exposed to psychotherapy alone under real world conditions. Participants exposed and unexposed to sertraline were followed for a maximum of 3 years.

Participants switched from 1 treatment to another throughout the study, irrespective in which arm they were enrolled. Hence, number of participants for reporting arms were different at different visits.

Participant milestones

Measure	Sertraline Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to United States prescribing information (USPI) provided by their physician. Participants in this group were on sertraline only or sertraline and any other treatment. Treatment here was the one which was planned for the participants at baseline.	Psychotherapy Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial/psychotherapy rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a selective serotonin reuptake inhibitor (SSRI) medication. Participants in this group were on psychotherapy only or no treatment at all.
Overall Study STARTED	696	245
Overall Study COMPLETED	330	102
Overall Study NOT COMPLETED	366	143

Reasons for withdrawal

Measure	Sertraline Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to United States prescribing information (USPI) provided by their physician. Participants in this group were on sertraline only or sertraline and any other treatment. Treatment here was the one which was planned for the participants at baseline.	Psychotherapy Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial/psychotherapy rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a selective serotonin reuptake inhibitor (SSRI) medication. Participants in this group were on psychotherapy only or no treatment at all.
Overall Study Withdrew Consent	92	39
Overall Study Patient/Family Moved	28	3
Overall Study Lost to Follow-up	192	93
Overall Study Death	1	0
Overall Study Other	52	8
Overall Study Reason Missing For Discontinuation	1	0

Baseline Characteristics

Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

Baseline characteristics by cohort

Measure	Sertraline n=695 Participants Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician.	Other Antidepressant n=3 Participants Use of other antidepressants at baseline was a study exclusion criterion, however, a few participants were enrolled who initiated treatment with an antidepressant.	Psychotherapy n=243 Participants Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication.	Total n=941 Participants Total of all reporting groups
Age, Continuous	12.2 years STANDARD_DEVIATION 2.9 • n=5 Participants	14.0 years STANDARD_DEVIATION 3.0 • n=7 Participants	11.0 years STANDARD_DEVIATION 2.9 • n=5 Participants	11.9 years STANDARD_DEVIATION 2.9 • n=4 Participants
Sex: Female, Male Female	405 Participants n=5 Participants	3 Participants n=7 Participants	130 Participants n=5 Participants	538 Participants n=4 Participants
Sex: Female, Male Male	290 Participants n=5 Participants	0 Participants n=7 Participants	113 Participants n=5 Participants	403 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	73 Participants n=5 Participants	1 Participants n=7 Participants	24 Participants n=5 Participants	98 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	622 Participants n=5 Participants	2 Participants n=7 Participants	219 Participants n=5 Participants	843 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	23 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	25 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	66 Participants n=5 Participants	0 Participants n=7 Participants	15 Participants n=5 Participants	81 Participants n=4 Participants
Race (NIH/OMB) White	588 Participants n=5 Participants	3 Participants n=7 Participants	208 Participants n=5 Participants	799 Participants n=4 Participants
Race (NIH/OMB) More than one race	14 Participants n=5 Participants	0 Participants n=7 Participants	13 Participants n=5 Participants	27 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

Outcome measures

Measure	Sertraline n=666 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=3 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=224 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Cognitive Function Using Trails B at Month 3 Baseline	1.03 Z-score Standard Deviation 2.3	1.23 Z-score Standard Deviation 1.0	0.61 Z-score Standard Deviation 1.8
Change From Baseline in Cognitive Function Using Trails B at Month 3 Change at Week 3	-0.39 Z-score Standard Deviation 1.6	-0.09 Z-score Standard Deviation 0.5	-0.03 Z-score Standard Deviation 2.3

PRIMARY outcome

Timeframe: Baseline, Month 6

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

Outcome measures

Measure	Sertraline n=460 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=35 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=159 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Cognitive Function Using Trails B at Month 6	-0.64 Z-score Standard Deviation 2.2	-0.65 Z-score Standard Deviation 1.0	-0.16 Z-score Standard Deviation 1.9

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

Outcome measures

Measure	Sertraline n=367 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=57 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=138 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Cognitive Function Using Trails B at Month 12	-0.72 Z-score Standard Deviation 2.3	-0.22 Z-score Standard Deviation 1.4	-0.27 Z-score Standard Deviation 2.4

PRIMARY outcome

Timeframe: Baseline, Month 18

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

Outcome measures

Measure	Sertraline n=290 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=70 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=138 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Cognitive Function Using Trails B at Month 18	-0.57 Z-score Standard Deviation 1.9	-0.65 Z-score Standard Deviation 2.2	-0.22 Z-score Standard Deviation 2.8

PRIMARY outcome

Timeframe: Baseline, Month 24

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

Outcome measures

Measure	Sertraline n=247 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=70 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=134 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Cognitive Function Using Trails B at Month 24	-0.44 Z-score Standard Deviation 2.2	-1.08 Z-score Standard Deviation 1.7	-0.18 Z-score Standard Deviation 3.4

PRIMARY outcome

Timeframe: Baseline, Month 30

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

Outcome measures

Measure	Sertraline n=209 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=63 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=141 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Cognitive Function Using Trails B at Month 30	-0.74 Z-score Standard Deviation 2.1	-0.61 Z-score Standard Deviation 2.4	-0.18 Z-score Standard Deviation 4.2

PRIMARY outcome

Timeframe: Baseline, Month 36

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.

Outcome measures

Measure	Sertraline n=193 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=56 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=154 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Cognitive Function Using Trails B at Month 36	-0.25 Z-score Standard Deviation 2.9	-0.13 Z-score Standard Deviation 3.6	-0.59 Z-score Standard Deviation 2.6

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

Outcome measures

Measure	Sertraline n=686 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=3 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=237 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3 Baseline	62.93 Z-score Standard Deviation 11.3	57.67 Z-score Standard Deviation 5.5	59.27 Z-score Standard Deviation 13.0
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3 Change at Week 3	-2.29 Z-score Standard Deviation 7.8	4.50 Z-score Standard Deviation 13.4	-1.88 Z-score Standard Deviation 7.3

PRIMARY outcome

Timeframe: Baseline, Month 6

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

Outcome measures

Measure	Sertraline n=467 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=35 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=166 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6	-2.53 Z-score Standard Deviation 8.8	-1.54 Z-score Standard Deviation 8.8	-2.74 Z-score Standard Deviation 8.7

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

Outcome measures

Measure	Sertraline n=370 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=58 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=140 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12	-3.12 Z-score Standard Deviation 9.1	-1.97 Z-score Standard Deviation 8.3	-2.81 Z-score Standard Deviation 9.0

PRIMARY outcome

Timeframe: Baseline, Month 18

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

Outcome measures

Measure	Sertraline n=290 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=69 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=140 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18	-2.40 Z-score Standard Deviation 9.2	-1.57 Z-score Standard Deviation 9.9	-3.13 Z-score Standard Deviation 8.3

PRIMARY outcome

Timeframe: Baseline, Month 24

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

Outcome measures

Measure	Sertraline n=248 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=66 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=133 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24	-3.37 Z-score Standard Deviation 10.0	-3.14 Z-score Standard Deviation 9.0	-4.16 Z-score Standard Deviation 9.5

PRIMARY outcome

Timeframe: Baseline, Month 30

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

Outcome measures

Measure	Sertraline n=200 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=59 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=135 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30	-3.60 Z-score Standard Deviation 11.2	-4.39 Z-score Standard Deviation 8.7	-4.53 Z-score Standard Deviation 10.2

PRIMARY outcome

Timeframe: Baseline, Month 36

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

Outcome measures

Measure	Sertraline n=184 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=54 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=141 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36	-3.96 Z-score Standard Deviation 12.1	-3.87 Z-score Standard Deviation 10.4	-4.62 Z-score Standard Deviation 10.9

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

Outcome measures

Measure	Sertraline n=692 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=3 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=238 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3 Change at Week 3	-3.08 Z-score Standard Deviation 9.1	-1.50 Z-score Standard Deviation 0.7	-2.39 Z-score Standard Deviation 7.4
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3 Baseline	65.15 Z-score Standard Deviation 12.0	58.67 Z-score Standard Deviation 4.0	61.88 Z-score Standard Deviation 12.6

PRIMARY outcome

Timeframe: Baseline, Month 6

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

Outcome measures

Measure	Sertraline n=472 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=36 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=167 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6	-4.06 Z-score Standard Deviation 9.4	-3.14 Z-score Standard Deviation 9.7	-3.62 Z-score Standard Deviation 8.9

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

Outcome measures

Measure	Sertraline n=373 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=59 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=140 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12	-5.42 Z-score Standard Deviation 10.1	-2.44 Z-score Standard Deviation 8.2	-5.01 Z-score Standard Deviation 9.5

PRIMARY outcome

Timeframe: Baseline, Month 18

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

Outcome measures

Measure	Sertraline n=294 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=71 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=140 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18	-5.21 Z-score Standard Deviation 9.9	-3.59 Z-score Standard Deviation 9.9	-4.48 Z-score Standard Deviation 9.2

PRIMARY outcome

Timeframe: Baseline, Month 24

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

Outcome measures

Measure	Sertraline n=252 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=68 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=133 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24	-6.21 Z-score Standard Deviation 11.2	-5.78 Z-score Standard Deviation 8.8	-6.05 Z-score Standard Deviation 9.9

PRIMARY outcome

Timeframe: Baseline, Month 30

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

Outcome measures

Measure	Sertraline n=204 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=61 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=136 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30	-6.92 Z-score Standard Deviation 10.8	-5.23 Z-score Standard Deviation 10.0	-6.53 Z-score Standard Deviation 10.4

PRIMARY outcome

Timeframe: Baseline, Month 36

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.

Outcome measures

Measure	Sertraline n=188 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=55 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=142 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36	-7.44 Z-score Standard Deviation 11.1	-7.24 Z-score Standard Deviation 10.6	-6.22 Z-score Standard Deviation 11.2

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on centers for disease control (CDC) norms for age and gender.

Outcome measures

Measure	Sertraline n=693 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=3 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=243 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Height at Month 3 Baseline	0.31 Z-score Standard Deviation 1.1	0.76 Z-score Standard Deviation 1.4	0.32 Z-score Standard Deviation 1.1
Change From Baseline in Height at Month 3 Change at Month 3	0.00 Z-score Standard Deviation 0.3	-0.03 Z-score Standard Deviation 0.1	-0.01 Z-score Standard Deviation 0.3

PRIMARY outcome

Timeframe: Baseline, Month 6

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=478 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=36 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=170 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Height at Month 6	-0.02 Z-score Standard Deviation 0.3	0.07 Z-score Standard Deviation 0.4	0.00 Z-score Standard Deviation 0.4

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=381 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=59 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=144 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Height at Month 12	-0.01 Z-score Standard Deviation 0.4	0.06 Z-score Standard Deviation 0.5	-0.04 Z-score Standard Deviation 0.4

PRIMARY outcome

Timeframe: Baseline, Month 18

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=305 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=74 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=145 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Height at Month 18	-0.03 Z-score Standard Deviation 0.5	0.00 Z-score Standard Deviation 0.5	-0.02 Z-score Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline, Month 24

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=263 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=70 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=138 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Height at Month 24	0.01 Z-score Standard Deviation 0.5	-0.02 Z-score Standard Deviation 0.6	-0.02 Z-score Standard Deviation 0.5

PRIMARY outcome

Timeframe: Baseline, Month 30

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=218 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=66 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=148 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Height at Month 30	0.01 Z-score Standard Deviation 0.7	-0.10 Z-score Standard Deviation 0.6	0.00 Z-score Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline, Month 36

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=203 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=62 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=160 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Height at Month 36	0.00 Z-score Standard Deviation 0.7	-0.04 Z-score Standard Deviation 0.7	-0.02 Z-score Standard Deviation 0.9

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=693 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=3 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=243 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Weight at Month 3 Baseline	0.58 Z-score Standard Deviation 1.2	0.88 Z-score Standard Deviation 0.7	0.42 Z-score Standard Deviation 1.0
Change From Baseline in Weight at Month 3 Change at Month 3	0.02 Z-score Standard Deviation 0.2	-0.22 Z-score Standard Deviation 0.1	-0.03 Z-score Standard Deviation 0.2

PRIMARY outcome

Timeframe: Baseline, Month 6

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=478 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=36 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=170 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Weight at Month 6	0.03 Z-score Standard Deviation 0.3	0.01 Z-score Standard Deviation 0.3	-0.05 Z-score Standard Deviation 0.3

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=382 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=59 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=144 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Weight at Month 12	0.10 Z-score Standard Deviation 0.4	0.06 Z-score Standard Deviation 0.5	0.00 Z-score Standard Deviation 0.4

PRIMARY outcome

Timeframe: Baseline, Month 18

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=305 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=74 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=145 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Weight at Month 18	0.14 Z-score Standard Deviation 0.5	0.07 Z-score Standard Deviation 0.6	-0.01 Z-score Standard Deviation 0.5

PRIMARY outcome

Timeframe: Baseline, Month 24

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=263 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=70 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=138 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Weight at Month 24	0.16 Z-score Standard Deviation 0.5	0.15 Z-score Standard Deviation 0.6	0.00 Z-score Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline, Month 30

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=218 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=66 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=148 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Weight at Month 30	0.16 Z-score Standard Deviation 0.6	0.11 Z-score Standard Deviation 0.6	0.04 Z-score Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline, Month 36

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=203 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=62 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=162 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Weight at Month 36	0.17 Z-score Standard Deviation 0.6	0.17 Z-score Standard Deviation 0.7	0.02 Z-score Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=693 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=3 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=243 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Body Mass Index (BMI) at Month 3 Baseline	0.48 Z-score Standard Deviation 1.3	0.79 Z-score Standard Deviation 0.4	0.27 Z-score Standard Deviation 1.3
Change From Baseline in Body Mass Index (BMI) at Month 3 Change at Month 3	0.02 Z-score Standard Deviation 0.3	-0.26 Z-score Standard Deviation 0.2	-0.03 Z-score Standard Deviation 0.3

PRIMARY outcome

Timeframe: Baseline, Month 6

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=478 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=36 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=170 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Body Mass Index (BMI) at Month 6	0.04 Z-score Standard Deviation 0.4	-0.03 Z-score Standard Deviation 0.4	-0.06 Z-score Standard Deviation 0.4

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=381 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=59 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=144 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Body Mass Index (BMI) at Month 12	0.13 Z-score Standard Deviation 0.5	0.06 Z-score Standard Deviation 0.6	0.04 Z-score Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline, Month 18

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=305 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=74 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=145 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Body Mass Index (BMI) at Month 18	0.18 Z-score Standard Deviation 0.6	0.07 Z-score Standard Deviation 0.8	-0.04 Z-score Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline, Month 24

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=263 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=70 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=138 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Body Mass Index (BMI) at Month 24	0.17 Z-score Standard Deviation 0.7	0.20 Z-score Standard Deviation 0.9	-0.01 Z-score Standard Deviation 0.7

PRIMARY outcome

Timeframe: Baseline, Month 30

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=218 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=66 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=148 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Body Mass Index (BMI) at Month 30	0.16 Z-score Standard Deviation 0.8	0.15 Z-score Standard Deviation 0.8	0.03 Z-score Standard Deviation 0.7

PRIMARY outcome

Timeframe: Baseline, Month 36

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.

Outcome measures

Measure	Sertraline n=203 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=62 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=160 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Body Mass Index (BMI) at Month 36	0.17 Z-score Standard Deviation 0.8	0.21 Z-score Standard Deviation 0.9	0.01 Z-score Standard Deviation 0.7

PRIMARY outcome

Timeframe: Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure. There were no male participants in reporting arm "Other Antidepressant" at Baseline, hence no data collected and evaluated.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=288 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=113 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males Stage 1	122 Participants	—	58 Participants
Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males Stage 2	53 Participants	—	20 Participants
Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males Stage 3	45 Participants	—	17 Participants
Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males Stage 4	53 Participants	—	15 Participants
Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males Stage 5	15 Participants	—	3 Participants

PRIMARY outcome

Timeframe: Month 3

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=230 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=1 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=80 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Month 3: All Males Stage 1	94 Participants	1 Participants	42 Participants
Number of Participants With Tanner Staging Evaluation at Month 3: All Males Stage 2	40 Participants	0 Participants	10 Participants
Number of Participants With Tanner Staging Evaluation at Month 3: All Males Stage 3	43 Participants	0 Participants	14 Participants
Number of Participants With Tanner Staging Evaluation at Month 3: All Males Stage 4	45 Participants	0 Participants	11 Participants
Number of Participants With Tanner Staging Evaluation at Month 3: All Males Stage 5	8 Participants	0 Participants	3 Participants

PRIMARY outcome

Timeframe: Month 6

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=203 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=14 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=77 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Month 6: All Males Stage 1	75 Participants	6 Participants	36 Participants
Number of Participants With Tanner Staging Evaluation at Month 6: All Males Stage 2	44 Participants	2 Participants	11 Participants
Number of Participants With Tanner Staging Evaluation at Month 6: All Males Stage 3	34 Participants	3 Participants	14 Participants
Number of Participants With Tanner Staging Evaluation at Month 6: All Males Stage 4	43 Participants	2 Participants	14 Participants
Number of Participants With Tanner Staging Evaluation at Month 6: All Males Stage 5	7 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Month 12

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=164 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=24 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=69 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Month 12: All Males Stage 1	55 Participants	7 Participants	30 Participants
Number of Participants With Tanner Staging Evaluation at Month 12: All Males Stage 2	37 Participants	2 Participants	11 Participants
Number of Participants With Tanner Staging Evaluation at Month 12: All Males Stage 3	26 Participants	5 Participants	12 Participants
Number of Participants With Tanner Staging Evaluation at Month 12: All Males Stage 4	36 Participants	8 Participants	12 Participants
Number of Participants With Tanner Staging Evaluation at Month 12: All Males Stage 5	10 Participants	2 Participants	4 Participants

PRIMARY outcome

Timeframe: Month 18

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=136 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=33 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=57 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Month 18: All Males Stage 1	39 Participants	9 Participants	20 Participants
Number of Participants With Tanner Staging Evaluation at Month 18: All Males Stage 2	31 Participants	5 Participants	11 Participants
Number of Participants With Tanner Staging Evaluation at Month 18: All Males Stage 3	19 Participants	6 Participants	12 Participants
Number of Participants With Tanner Staging Evaluation at Month 18: All Males Stage 4	33 Participants	7 Participants	9 Participants
Number of Participants With Tanner Staging Evaluation at Month 18: All Males Stage 5	14 Participants	6 Participants	5 Participants

PRIMARY outcome

Timeframe: Month 24

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=112 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=34 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=62 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Month 24: All Males Stage 1	32 Participants	7 Participants	13 Participants
Number of Participants With Tanner Staging Evaluation at Month 24: All Males Stage 2	27 Participants	9 Participants	12 Participants
Number of Participants With Tanner Staging Evaluation at Month 24: All Males Stage 3	17 Participants	6 Participants	14 Participants
Number of Participants With Tanner Staging Evaluation at Month 24: All Males Stage 4	22 Participants	6 Participants	16 Participants
Number of Participants With Tanner Staging Evaluation at Month 24: All Males Stage 5	14 Participants	6 Participants	7 Participants

PRIMARY outcome

Timeframe: Month 30

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=86 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=33 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=64 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Month 30: All Males Stage 1	23 Participants	5 Participants	10 Participants
Number of Participants With Tanner Staging Evaluation at Month 30: All Males Stage 2	18 Participants	7 Participants	8 Participants
Number of Participants With Tanner Staging Evaluation at Month 30: All Males Stage 3	16 Participants	5 Participants	19 Participants
Number of Participants With Tanner Staging Evaluation at Month 30: All Males Stage 4	15 Participants	6 Participants	19 Participants
Number of Participants With Tanner Staging Evaluation at Month 30: All Males Stage 5	14 Participants	10 Participants	8 Participants

PRIMARY outcome

Timeframe: Month 36

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=84 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=34 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=75 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Month 36: All Males Stage 1	18 Participants	6 Participants	7 Participants
Number of Participants With Tanner Staging Evaluation at Month 36: All Males Stage 2	18 Participants	4 Participants	12 Participants
Number of Participants With Tanner Staging Evaluation at Month 36: All Males Stage 3	14 Participants	10 Participants	15 Participants
Number of Participants With Tanner Staging Evaluation at Month 36: All Males Stage 4	22 Participants	4 Participants	25 Participants
Number of Participants With Tanner Staging Evaluation at Month 36: All Males Stage 5	12 Participants	10 Participants	16 Participants

PRIMARY outcome

Timeframe: Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=401 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=3 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=130 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Baseline: All Females Stage 2	40 Participants	0 Participants	21 Participants
Number of Participants With Tanner Staging Evaluation at Baseline: All Females Stage 3	61 Participants	0 Participants	25 Participants
Number of Participants With Tanner Staging Evaluation at Baseline: All Females Stage 1	81 Participants	1 Participants	39 Participants
Number of Participants With Tanner Staging Evaluation at Baseline: All Females Stage 4	146 Participants	1 Participants	28 Participants
Number of Participants With Tanner Staging Evaluation at Baseline: All Females Stage 5	73 Participants	1 Participants	17 Participants

PRIMARY outcome

Timeframe: Month 3

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=323 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=2 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=94 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Month 3: All Females Stage 1	59 Participants	1 Participants	30 Participants
Number of Participants With Tanner Staging Evaluation at Month 3: All Females Stage 2	37 Participants	0 Participants	13 Participants
Number of Participants With Tanner Staging Evaluation at Month 3: All Females Stage 3	47 Participants	0 Participants	14 Participants
Number of Participants With Tanner Staging Evaluation at Month 3: All Females Stage 4	108 Participants	0 Participants	24 Participants
Number of Participants With Tanner Staging Evaluation at Month 3: All Females Stage 5	72 Participants	1 Participants	13 Participants

PRIMARY outcome

Timeframe: Month 6

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=275 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=22 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=91 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Month 6: All Females Stage 1	43 Participants	1 Participants	22 Participants
Number of Participants With Tanner Staging Evaluation at Month 6: All Females Stage 2	31 Participants	4 Participants	13 Participants
Number of Participants With Tanner Staging Evaluation at Month 6: All Females Stage 3	46 Participants	2 Participants	18 Participants
Number of Participants With Tanner Staging Evaluation at Month 6: All Females Stage 4	90 Participants	10 Participants	18 Participants
Number of Participants With Tanner Staging Evaluation at Month 6: All Females Stage 5	65 Participants	5 Participants	20 Participants

PRIMARY outcome

Timeframe: Month 12

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=218 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=35 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=75 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Month 12: All Females Stage 1	27 Participants	5 Participants	9 Participants
Number of Participants With Tanner Staging Evaluation at Month 12: All Females Stage 2	27 Participants	2 Participants	15 Participants
Number of Participants With Tanner Staging Evaluation at Month 12: All Females Stage 3	31 Participants	5 Participants	12 Participants
Number of Participants With Tanner Staging Evaluation at Month 12: All Females Stage 4	71 Participants	11 Participants	24 Participants
Number of Participants With Tanner Staging Evaluation at Month 12: All Females Stage 5	62 Participants	12 Participants	15 Participants

PRIMARY outcome

Timeframe: Month 18

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=169 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=40 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=88 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Month 18: All Females Stage 1	17 Participants	4 Participants	9 Participants
Number of Participants With Tanner Staging Evaluation at Month 18: All Females Stage 2	14 Participants	2 Participants	14 Participants
Number of Participants With Tanner Staging Evaluation at Month 18: All Females Stage 3	22 Participants	2 Participants	13 Participants
Number of Participants With Tanner Staging Evaluation at Month 18: All Females Stage 4	57 Participants	14 Participants	31 Participants
Number of Participants With Tanner Staging Evaluation at Month 18: All Females Stage 5	59 Participants	18 Participants	21 Participants

PRIMARY outcome

Timeframe: Month 24

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=151 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=37 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=76 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Month 24: All Females Stage 1	13 Participants	2 Participants	8 Participants
Number of Participants With Tanner Staging Evaluation at Month 24: All Females Stage 2	15 Participants	3 Participants	10 Participants
Number of Participants With Tanner Staging Evaluation at Month 24: All Females Stage 3	16 Participants	1 Participants	13 Participants
Number of Participants With Tanner Staging Evaluation at Month 24: All Females Stage 4	49 Participants	11 Participants	24 Participants
Number of Participants With Tanner Staging Evaluation at Month 24: All Females Stage 5	58 Participants	20 Participants	21 Participants

PRIMARY outcome

Timeframe: Month 30

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=132 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=33 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=84 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Month 30: All Females Stage 1	10 Participants	1 Participants	3 Participants
Number of Participants With Tanner Staging Evaluation at Month 30: All Females Stage 2	15 Participants	2 Participants	9 Participants
Number of Participants With Tanner Staging Evaluation at Month 30: All Females Stage 3	15 Participants	1 Participants	8 Participants
Number of Participants With Tanner Staging Evaluation at Month 30: All Females Stage 4	34 Participants	8 Participants	29 Participants
Number of Participants With Tanner Staging Evaluation at Month 30: All Females Stage 5	58 Participants	21 Participants	35 Participants

PRIMARY outcome

Timeframe: Month 36

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.

Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).

Outcome measures

Measure	Sertraline n=120 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=30 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=88 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants With Tanner Staging Evaluation at Month 36: All Females Stage 1	9 Participants	0 Participants	2 Participants
Number of Participants With Tanner Staging Evaluation at Month 36: All Females Stage 2	9 Participants	2 Participants	9 Participants
Number of Participants With Tanner Staging Evaluation at Month 36: All Females Stage 3	9 Participants	7 Participants	8 Participants
Number of Participants With Tanner Staging Evaluation at Month 36: All Females Stage 4	32 Participants	7 Participants	25 Participants
Number of Participants With Tanner Staging Evaluation at Month 36: All Females Stage 5	61 Participants	14 Participants	44 Participants

SECONDARY outcome

Timeframe: Month 3, 6, 12, 18, 24, 30 and 36

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

CGI-I scale was a 7-point scale used to rate improvement in the participant's condition (benefits). Scale range/categories: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = Not changed, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher score indicated worse condition.

Outcome measures

Measure	Sertraline n=556 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=73 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=176 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Minimally Worse	1 Participants	1 Participants	1 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Much Worse	4 Participants	2 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Very Much Worse	1 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Very Much Improved	77 Participants	0 Participants	17 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Much Improved	223 Participants	0 Participants	51 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Minimally Improved	151 Participants	1 Participants	69 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Not Changed	63 Participants	1 Participants	29 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Minimally Worse	20 Participants	0 Participants	3 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Much Worse	21 Participants	0 Participants	5 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Very Much Worse	1 Participants	1 Participants	2 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Very Much Improved	96 Participants	2 Participants	29 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Much Improved	220 Participants	14 Participants	64 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Minimally Improved	87 Participants	7 Participants	48 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Not Changed	44 Participants	8 Participants	21 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Minimally Worse	15 Participants	0 Participants	2 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Much Worse	12 Participants	3 Participants	2 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Very Much Worse	4 Participants	0 Participants	1 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Very Much Improved	93 Participants	9 Participants	32 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Much Improved	174 Participants	19 Participants	55 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Minimally Improved	80 Participants	20 Participants	28 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Not Changed	16 Participants	6 Participants	18 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Minimally Worse	7 Participants	1 Participants	2 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Much Worse	9 Participants	2 Participants	6 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Very Much Worse	3 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Very Much Improved	86 Participants	14 Participants	32 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Much Improved	136 Participants	34 Participants	55 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Minimally Improved	53 Participants	11 Participants	34 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Not Changed	14 Participants	10 Participants	11 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Minimally Worse	6 Participants	1 Participants	2 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Much Worse	7 Participants	2 Participants	5 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Very Much Worse	2 Participants	1 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Very Much Improved	93 Participants	10 Participants	34 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Much Improved	113 Participants	39 Participants	53 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Minimally Improved	34 Participants	10 Participants	27 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Not Changed	16 Participants	9 Participants	9 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Minimally Worse	5 Participants	2 Participants	2 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Much Worse	0 Participants	0 Participants	4 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Very Much Worse	1 Participants	0 Participants	1 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Very Much Improved	73 Participants	12 Participants	43 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Much Improved	102 Participants	41 Participants	63 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Minimally Improved	21 Participants	8 Participants	23 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Not Changed	12 Participants	2 Participants	12 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Minimally Worse	4 Participants	1 Participants	1 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Much Worse	1 Participants	0 Participants	1 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Very Much Worse	1 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Very Much Improved	85 Participants	22 Participants	53 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Much Improved	85 Participants	27 Participants	77 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Minimally Improved	22 Participants	9 Participants	15 Participants
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Not Changed	5 Participants	3 Participants	8 Participants

SECONDARY outcome

Timeframe: Month 3, 6, 12, 18, 24, 30 and 36

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

CGI-T scale was a 7-point scale used to assess the tolerability of the study medication with respect to adverse events. Scale range/categories: 1= very high, 2= high, 3= above average, 4= average, 5= low, 6= very low, and 7= extremely low. Higher score indicated less tolerability with study medication.

Outcome measures

Measure	Sertraline n=546 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=65 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=96 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Average	7 Participants	5 Participants	7 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Very High	274 Participants	0 Participants	25 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · High	123 Participants	0 Participants	18 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Above Average	40 Participants	0 Participants	18 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Average	69 Participants	2 Participants	30 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Low	22 Participants	0 Participants	3 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Very Low	10 Participants	0 Participants	2 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Extremely Low	8 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Very High	245 Participants	14 Participants	33 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · High	116 Participants	4 Participants	12 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Above Average	28 Participants	1 Participants	20 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Average	49 Participants	6 Participants	23 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Low	19 Participants	2 Participants	2 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Very Low	5 Participants	1 Participants	4 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Extremely Low	6 Participants	1 Participants	1 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Very High	217 Participants	23 Participants	30 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · High	84 Participants	12 Participants	14 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Very Low	2 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Extremely Low	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Above Average	19 Participants	3 Participants	12 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Average	35 Participants	10 Participants	14 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Low	11 Participants	4 Participants	4 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Very Low	1 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Extremely Low	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Very High	170 Participants	32 Participants	35 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · High	77 Participants	15 Participants	9 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Above Average	16 Participants	3 Participants	7 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Average	26 Participants	10 Participants	11 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Low	5 Participants	3 Participants	6 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Very Low	2 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Extremely Low	2 Participants	1 Participants	1 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Very High	149 Participants	37 Participants	33 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · High	67 Participants	17 Participants	12 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Above Average	9 Participants	5 Participants	3 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Average	19 Participants	3 Participants	8 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Low	4 Participants	3 Participants	4 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Very High	132 Participants	29 Participants	35 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · High	55 Participants	18 Participants	5 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Above Average	7 Participants	6 Participants	6 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Average	12 Participants	5 Participants	9 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Low	2 Participants	1 Participants	1 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Very Low	1 Participants	0 Participants	1 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Extremely Low	1 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Very High	125 Participants	35 Participants	32 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · High	51 Participants	12 Participants	10 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Above Average	11 Participants	3 Participants	6 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Low	0 Participants	1 Participants	2 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Very Low	1 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Extremely Low	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Month 3, 6, 12, 18, 24, 30 and 36

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

The CGI-E was the value at which the participant's therapeutic benefit and adverse impact to the study drug intersected. Firstly clinician identified the degree of therapeutic benefit on scale range: very much improved, much improved, minimally improved, unchanged or worse. Secondly, the clinician rater identified the degree to which problems with tolerability adversely impact the participant on scale range: no adverse impact, mild adverse impact, moderate adverse impact, outweighs therapeutic effect. Finally, clinician identified in which participants benefits and adverse impacts intersected. Participants were then determined to be responders or non-responders to the study medication.

Outcome measures

Measure	Sertraline n=544 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=67 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=130 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Responders at Month 3	296 Participants	1 Participants	55 Participants
Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Responders at Month 6	309 Participants	14 Participants	72 Participants
Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Responders at Month 12	268 Participants	28 Participants	52 Participants
Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Responders at Month 18	219 Participants	44 Participants	54 Participants
Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Responders at Month 24	206 Participants	47 Participants	54 Participants
Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Responders at Month 30	173 Participants	52 Participants	66 Participants
Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 Responders at Month 36	169 Participants	46 Participants	72 Participants

SECONDARY outcome

Timeframe: Baseline, Month 3, 6, 12, 18, 24, 30 and 36

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

CGI-S scale was a 7-point scale used to assess severity of illness on a range of 1 to 7; where, 1= normal, not mentally ill, 2= borderline mentally ill, 3= mildly mentally ill, 4= moderately mentally ill, 5= markedly mentally ill, 6= severely mentally ill, and 7= among the most extremely mentally. Higher score indicated worse condition.

Outcome measures

Measure	Sertraline n=692 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=74 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=243 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Severely Mentally ill	5 Participants	3 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Among the Most Extremely Mentally ill	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Normal, Not Mentally ill	39 Participants	4 Participants	25 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Borderline Mentally ill	61 Participants	10 Participants	29 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Mildly Mentally ill	100 Participants	17 Participants	48 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Moderately Mentally ill	48 Participants	35 Participants	31 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Markedly Mentally ill	13 Participants	5 Participants	5 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Baseline · Normal, Not Mentally ill	21 Participants	0 Participants	29 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Baseline · Borderline Mentally ill	28 Participants	0 Participants	17 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Baseline · Mildly Mentally ill	138 Participants	0 Participants	57 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Baseline · Moderately Mentally ill	377 Participants	3 Participants	107 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Baseline · Markedly Mentally ill	116 Participants	0 Participants	31 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Baseline · Severely Mentally ill	12 Participants	0 Participants	2 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Baseline · Among the Most Extremely Mentally ill	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Normal, Not Mentally ill	32 Participants	0 Participants	18 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Borderline Mentally ill	87 Participants	0 Participants	19 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Mildly Mentally ill	163 Participants	1 Participants	60 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Moderately Mentally ill	216 Participants	0 Participants	54 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Markedly Mentally ill	55 Participants	1 Participants	23 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Severely Mentally ill	3 Participants	1 Participants	4 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 3 · Among the Most Extremely Mentally ill	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Normal, Not Mentally ill	44 Participants	1 Participants	28 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Borderline Mentally ill	93 Participants	4 Participants	33 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Mildly Mentally ill	139 Participants	9 Participants	51 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Moderately Mentally ill	162 Participants	15 Participants	43 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Markedly Mentally ill	31 Participants	6 Participants	14 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Severely Mentally ill	10 Participants	1 Participants	3 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 6 · Among the Most Extremely Mentally ill	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Normal, Not Mentally ill	42 Participants	2 Participants	32 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Borderline Mentally ill	80 Participants	6 Participants	31 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Mildly Mentally ill	133 Participants	13 Participants	39 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Moderately Mentally ill	100 Participants	26 Participants	29 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Markedly Mentally ill	22 Participants	11 Participants	11 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Severely Mentally ill	6 Participants	1 Participants	4 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 12 · Among the Most Extremely Mentally ill	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Normal, Not Mentally ill	35 Participants	1 Participants	26 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Borderline Mentally ill	66 Participants	13 Participants	29 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Mildly Mentally ill	106 Participants	19 Participants	53 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Moderately Mentally ill	76 Participants	33 Participants	34 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 18 · Markedly Mentally ill	16 Participants	5 Participants	7 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Severely Mentally ill	2 Participants	0 Participants	1 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 24 · Among the Most Extremely Mentally ill	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Normal, Not Mentally ill	30 Participants	5 Participants	33 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Borderline Mentally ill	58 Participants	13 Participants	27 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Mildly Mentally ill	78 Participants	25 Participants	55 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Moderately Mentally ill	45 Participants	19 Participants	29 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Markedly Mentally ill	6 Participants	3 Participants	4 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Severely Mentally ill	1 Participants	1 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 30 · Among the Most Extremely Mentally ill	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Normal, Not Mentally ill	36 Participants	10 Participants	46 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Borderline Mentally ill	54 Participants	13 Participants	31 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Mildly Mentally ill	72 Participants	20 Participants	55 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Moderately Mentally ill	33 Participants	16 Participants	25 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Markedly Mentally ill	7 Participants	4 Participants	6 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Severely Mentally ill	2 Participants	1 Participants	0 Participants
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 Month 36 · Among the Most Extremely Mentally ill	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Month 3, 6, 12, 18, 24, 30 and 36

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

CGAS was to rate the general functioning of the study participants on a numeric scale of 1 to 100, where 1= extremely impaired and 100= doing very well.

Outcome measures

Measure	Sertraline n=691 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=74 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=243 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 Change at Month 30	12.37 Units on scale Standard Deviation 13.1	9.94 Units on scale Standard Deviation 11.4	12.54 Units on scale Standard Deviation 13.0
Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 Baseline	55.80 Units on scale Standard Deviation 10.0	56.67 Units on scale Standard Deviation 5.8	59.86 Units on scale Standard Deviation 10.9
Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 Change at Month 3	6.58 Units on scale Standard Deviation 10.8	-7.67 Units on scale Standard Deviation 8.7	4.61 Units on scale Standard Deviation 9.8
Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 Change at Month 6	8.24 Units on scale Standard Deviation 11.6	1.08 Units on scale Standard Deviation 16.5	8.23 Units on scale Standard Deviation 11.0
Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 Change at Month 12	10.02 Units on scale Standard Deviation 12.6	4.48 Units on scale Standard Deviation 9.4	10.66 Units on scale Standard Deviation 12.7
Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 Change at Month 18	10.51 Units on scale Standard Deviation 11.7	6.76 Units on scale Standard Deviation 10.5	12.46 Units on scale Standard Deviation 12.2
Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 Change at Month 24	11.29 Units on scale Standard Deviation 12.0	8.44 Units on scale Standard Deviation 11.3	11.29 Units on scale Standard Deviation 12.8
Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 Change at Month 36	13.05 Units on scale Standard Deviation 12.9	8.77 Units on scale Standard Deviation 10.7	15.28 Units on scale Standard Deviation 13.6

SECONDARY outcome

Timeframe: Baseline, Month 3, 6, 12, 18, 24, 30 and 36

Population: Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

HoNOSCA scale had 13-sub-scales used to assess general health and social functioning. 13 sub-scales were as the following: disruptive or aggressive behavior, attention deficit hyperactivity disorder (ADHD), self-harm, substance abuse, school problems, physical illness, psychosis, physical symptoms, internalizing symptoms, peer relationships, self-care, family relationships and school attendance problems. Each sub-scale had a range of 0 (no problems) to 4 (severe problems). Scores from all 13 sub-scales were summed up to give overall possible HoNOSCA total score range of 0 to 52. Higher score indicated worse condition.

Outcome measures

Measure	Sertraline n=685 Participants At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.	Other Antidepressants n=72 Participants At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.	Psychotherapy n=241 Participants At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 Change at Month 30	-4.04 Units on scale Standard Deviation 4.8	-4.75 Units on scale Standard Deviation 4.6	-4.80 Units on scale Standard Deviation 5.1
Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 Change at Month 36	-4.33 Units on scale Standard Deviation 5.3	-4.69 Units on scale Standard Deviation 4.7	-5.30 Units on scale Standard Deviation 5.1
Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 Baseline	10.51 Units on scale Standard Deviation 5.4	8.33 Units on scale Standard Deviation 3.2	9.19 Units on scale Standard Deviation 4.6
Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 Change at Month 3	-2.75 Units on scale Standard Deviation 4.8	4.33 Units on scale Standard Deviation 6.4	-2.05 Units on scale Standard Deviation 4.2
Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 Change at Month 6	-3.23 Units on scale Standard Deviation 5.1	-0.14 Units on scale Standard Deviation 6.0	-3.21 Units on scale Standard Deviation 4.7
Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 Change at Month 12	-3.79 Units on scale Standard Deviation 5.5	-2.46 Units on scale Standard Deviation 5.8	-3.88 Units on scale Standard Deviation 4.8
Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 Change at Month 18	-3.98 Units on scale Standard Deviation 5.6	-3.53 Units on scale Standard Deviation 5.8	-3.79 Units on scale Standard Deviation 4.6
Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 Change at Month 24	-3.96 Units on scale Standard Deviation 5.4	-5.07 Units on scale Standard Deviation 6.0	-4.57 Units on scale Standard Deviation 4.7

Adverse Events

Sertraline (Baseline)

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Other Antidepressants (Baseline)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Psychotherapy (Baseline)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sertraline (Month 3)

Serious events: 27 serious events

Other events: 201 other events

Deaths: 0 deaths

Other Antidepressants (Month 3)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Psychotherapy (Month 3)

Serious events: 9 serious events

Other events: 54 other events

Deaths: 0 deaths

Sertraline (Month 6)

Serious events: 19 serious events

Other events: 153 other events

Deaths: 0 deaths

Other Antidepressants (Month 6)

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Psychotherapy (Month 6)

Serious events: 2 serious events

Other events: 47 other events

Deaths: 0 deaths

Sertraline (Month 12)

Serious events: 11 serious events

Other events: 118 other events

Deaths: 0 deaths

Other Antidepressants (Month 12)

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Psychotherapy (Month 12)

Serious events: 7 serious events

Other events: 42 other events

Deaths: 0 deaths

Sertraline (Month 18)

Serious events: 11 serious events

Other events: 88 other events

Deaths: 0 deaths

Other Antidepressants (Month 18)

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Psychotherapy (Month 18)

Serious events: 4 serious events

Other events: 33 other events

Deaths: 0 deaths

Sertraline (Month 24)

Serious events: 6 serious events

Other events: 57 other events

Deaths: 0 deaths

Other Antidepressants (Month 24)

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Psychotherapy (Month 24)

Serious events: 3 serious events

Other events: 31 other events

Deaths: 0 deaths

Sertraline (Month 30)

Serious events: 2 serious events

Other events: 47 other events

Deaths: 1 deaths

Other Antidepressants (Month 30)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Psychotherapy (Month 30)

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Sertraline (Month 36)

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

Other Antidepressants (Month 36)

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Psychotherapy (Month 36)

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sertraline (Baseline) n=614 participants at risk Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician.	Other Antidepressants (Baseline) n=3 participants at risk Use of other antidepressants at baseline was a study exclusion criterion, however, a few participants were enrolled who initiated treatment with an antidepressant.	Psychotherapy (Baseline) n=181 participants at risk Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication.	Sertraline (Month 3) n=622 participants at risk Participants in this group were on sertraline only or sertraline and any other treatment at Month 3 visit.	Other Antidepressants (Month 3) n=19 participants at risk Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 3 visit.	Psychotherapy (Month 3) n=384 participants at risk Participants in this group were on psychotherapy only or no treatment at all at Month 3 visit.	Sertraline (Month 6) n=516 participants at risk Participants in this group were on sertraline only or sertraline and any other treatment at Month 6 visit.	Other Antidepressants (Month 6) n=48 participants at risk Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 6 visit.	Psychotherapy (Month 6) n=181 participants at risk Participants in this group were on psychotherapy only or no treatment at all at Month 6 visit.	Sertraline (Month 12) n=426 participants at risk Participants in this group were on sertraline only or sertraline and any other treatment at Month 12 visit.	Other Antidepressants (Month 12) n=80 participants at risk Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 12 visit.	Psychotherapy (Month 12) n=181 participants at risk Participants in this group were on psychotherapy only or no treatment at all at Month 12 visit.	Sertraline (Month 18) n=335 participants at risk Participants in this group were on sertraline only or sertraline and any other treatment at Month 18 visit.	Other Antidepressants (Month 18) n=84 participants at risk Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 18 visit.	Psychotherapy (Month 18) n=181 participants at risk Participants in this group were on psychotherapy only or no treatment at all at Month 18 visit.	Sertraline (Month 24) n=289 participants at risk Participants in this group were on sertraline only or sertraline and any other treatment at Month 24 visit.	Other Antidepressants (Month 24) n=83 participants at risk Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 24 visit.	Psychotherapy (Month 24) n=181 participants at risk Participants in this group were on psychotherapy only or no treatment at all at Month 24 visit.	Sertraline (Month 30) n=240 participants at risk Participants in this group were on sertraline only or sertraline and any other treatment at Month 30 visit.	Other Antidepressants (Month 30) n=85 participants at risk Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 30 visit.	Psychotherapy (Month 30) n=181 participants at risk Participants in this group were on psychotherapy only or no treatment at all at Month 30 visit.	Sertraline (Month 36) n=207 participants at risk Participants in this group were on sertraline only or sertraline and any other treatment at Month 36 visit.	Other Antidepressants (Month 36) n=73 participants at risk Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 36 visit.	Psychotherapy (Month 36) n=181 participants at risk Participants in this group were on psychotherapy only or no treatment at all at Month 36 visit.
Psychiatric disorders Behaviour disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Conversion disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Appendicitis	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Hypersomnia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Anxiety	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Hostility	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Overdose	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Pyelonephritis acute	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Seizure	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Pneumonia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 1/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
General disorders Drug ineffective	0.49% 3/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Abdominal pain	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Diarrhoea	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Nausea	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Vomiting	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Concussion	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.64% 4/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Post concussion syndrome	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Investigations Liver function test increased	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Anticholinergic syndrome	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Serotonin syndrome	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Aggression	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.39% 2/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Agitation	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Anger	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Depression	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.96% 6/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Emotional disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Homicidal ideation	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Intentional self-injury	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 7/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Mental status changes	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Psychotic disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Self-injurious ideation	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Suicidal behaviour	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.64% 4/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	5.3% 1/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.78% 3/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.78% 4/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.47% 2/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Suicidal ideation	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.6% 10/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	5.3% 1/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.6% 6/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 9/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 5/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.2% 4/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.8% 6/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 3/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 4/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.6% 3/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 3/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 3/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.1% 3/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Suicide attempt	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.64% 4/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.78% 4/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.47% 2/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Blood and lymphatic system disorders Anaemia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Dizziness	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Syncope	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Depressed mood	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.39% 2/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.

Other adverse events

Measure	Sertraline (Baseline) n=614 participants at risk Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician.	Other Antidepressants (Baseline) n=3 participants at risk Use of other antidepressants at baseline was a study exclusion criterion, however, a few participants were enrolled who initiated treatment with an antidepressant.	Psychotherapy (Baseline) n=181 participants at risk Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication.	Sertraline (Month 3) n=622 participants at risk Participants in this group were on sertraline only or sertraline and any other treatment at Month 3 visit.	Other Antidepressants (Month 3) n=19 participants at risk Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 3 visit.	Psychotherapy (Month 3) n=384 participants at risk Participants in this group were on psychotherapy only or no treatment at all at Month 3 visit.	Sertraline (Month 6) n=516 participants at risk Participants in this group were on sertraline only or sertraline and any other treatment at Month 6 visit.	Other Antidepressants (Month 6) n=48 participants at risk Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 6 visit.	Psychotherapy (Month 6) n=181 participants at risk Participants in this group were on psychotherapy only or no treatment at all at Month 6 visit.	Sertraline (Month 12) n=426 participants at risk Participants in this group were on sertraline only or sertraline and any other treatment at Month 12 visit.	Other Antidepressants (Month 12) n=80 participants at risk Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 12 visit.	Psychotherapy (Month 12) n=181 participants at risk Participants in this group were on psychotherapy only or no treatment at all at Month 12 visit.	Sertraline (Month 18) n=335 participants at risk Participants in this group were on sertraline only or sertraline and any other treatment at Month 18 visit.	Other Antidepressants (Month 18) n=84 participants at risk Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 18 visit.	Psychotherapy (Month 18) n=181 participants at risk Participants in this group were on psychotherapy only or no treatment at all at Month 18 visit.	Sertraline (Month 24) n=289 participants at risk Participants in this group were on sertraline only or sertraline and any other treatment at Month 24 visit.	Other Antidepressants (Month 24) n=83 participants at risk Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 24 visit.	Psychotherapy (Month 24) n=181 participants at risk Participants in this group were on psychotherapy only or no treatment at all at Month 24 visit.	Sertraline (Month 30) n=240 participants at risk Participants in this group were on sertraline only or sertraline and any other treatment at Month 30 visit.	Other Antidepressants (Month 30) n=85 participants at risk Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 30 visit.	Psychotherapy (Month 30) n=181 participants at risk Participants in this group were on psychotherapy only or no treatment at all at Month 30 visit.	Sertraline (Month 36) n=207 participants at risk Participants in this group were on sertraline only or sertraline and any other treatment at Month 36 visit.	Other Antidepressants (Month 36) n=73 participants at risk Participants in this group were on another antidepressant only or another antidepressant and psychotherapy at Month 36 visit.	Psychotherapy (Month 36) n=181 participants at risk Participants in this group were on psychotherapy only or no treatment at all at Month 36 visit.
Investigations Weight increased	0.16% 1/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 13/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.78% 3/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.3% 12/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.6% 7/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.8% 3/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.8% 6/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.4% 2/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 6/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.4% 2/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Abdominal pain	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 9/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.78% 3/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 11/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.8% 5/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 5/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 3/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.90% 3/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 4/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 3/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.97% 2/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Diarrhoea	0.16% 1/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.96% 6/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.0% 4/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 9/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.70% 3/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.90% 3/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.69% 2/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Nausea	0.16% 1/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.64% 4/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	5.3% 1/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.3% 5/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 6/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.94% 4/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.8% 6/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.69% 2/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.4% 2/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 1/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Vomiting	0.16% 1/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.96% 6/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.78% 3/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.58% 3/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.47% 2/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
General disorders Fatigue	0.33% 2/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.8% 11/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.78% 3/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 6/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.8% 5/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.9% 8/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.5% 5/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 1/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Metabolism and nutrition disorders Decreased appetite	0.33% 2/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 13/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 8/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.97% 5/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.94% 4/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.5% 5/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 4/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.83% 2/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.97% 2/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 1/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Dizziness	0.16% 1/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.80% 5/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.78% 4/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.5% 5/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.69% 2/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 4/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Anxiety	0.16% 1/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.2% 26/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	5.3% 1/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 8/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	6.4% 33/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.4% 8/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.5% 19/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	5.0% 9/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.5% 15/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.8% 4/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.8% 5/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.8% 14/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.8% 4/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.4% 8/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 4/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.9% 8/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.2% 4/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Depressed mood	0.49% 3/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.7% 23/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 8/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 11/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.8% 5/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.3% 14/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.2% 4/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.7% 9/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	6.0% 5/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.2% 4/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 4/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	6.0% 5/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.8% 5/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.9% 7/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.8% 5/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.4% 5/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.7% 2/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.2% 4/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Hostility	0.65% 4/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.5% 22/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	5.3% 1/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.3% 9/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.7% 19/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.3% 6/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.0% 17/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.8% 3/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 3/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.3% 11/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.8% 5/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 6/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.4% 2/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 3/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 3/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 1/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.8% 5/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Insomnia	0.16% 1/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.6% 10/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.78% 3/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 9/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.6% 7/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.4% 8/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.0% 3/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Irritability	0.16% 1/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.7% 29/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	10.5% 2/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.8% 7/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.1% 21/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.4% 8/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 9/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.5% 2/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.4% 8/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 7/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	5.0% 9/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 6/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.8% 4/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.8% 5/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 4/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.5% 3/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.97% 2/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.8% 5/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Nightmare	0.16% 1/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Cardiac disorders Arrhythmia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Eye disorders Conjunctivitis allergic	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Congenital, familial and genetic disorders Albright's disease	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Eye disorders Vision blurred	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Constipation	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Dry mouth	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.52% 2/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.39% 2/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Dyspepsia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Eructation	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
General disorders Pain	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
General disorders Thirst	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Bronchitis	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Ear infection	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Gastroenteritis	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Gastroenteritis viral	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations H1N1 influenza	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Impetigo	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Influenza	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Nasopharyngitis	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Pharyngitis streptococcal	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.47% 2/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Tonsillitis streptococcal	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Upper respiratory tract infection	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 1/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Sinusitis	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Back injury	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Contusion	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.64% 4/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Corneal abrasion	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Communication disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Intentional product misuse	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Medication error	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Investigations Weight decreased	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.64% 4/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.0% 4/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.70% 3/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Frustration tolerance decreased	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Metabolism and nutrition disorders Increased appetite	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.78% 3/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.39% 2/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.94% 4/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.90% 3/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Akathisia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.80% 5/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.52% 2/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.58% 3/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.47% 2/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Disturbance in attention	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.9% 12/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.6% 6/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 7/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	5.0% 9/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.3% 10/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 3/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.4% 8/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.0% 3/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 3/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.5% 3/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 3/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Headache	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.1% 19/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.3% 9/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.1% 16/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.2% 2/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.3% 6/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 6/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 3/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 4/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.4% 2/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.4% 7/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.83% 2/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.4% 2/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.97% 2/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 3/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Hypersomnia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.90% 3/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Psychomotor hyperactivity	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.52% 2/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Abnormal dreams	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Affect lability	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.8% 11/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.0% 4/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.6% 8/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.8% 5/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.6% 7/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.2% 4/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 4/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 3/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.69% 2/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Aggression	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.8% 11/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.78% 3/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.9% 10/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.70% 3/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.90% 3/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	3.5% 3/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 1/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Apathy	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.96% 6/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.90% 3/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Blunted affect	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Compulsions	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Depression	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.58% 3/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Dermatillomania	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Enuresis	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 3/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.39% 2/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.60% 2/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Euphoric mood	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.58% 3/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.47% 2/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Hallucination	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Impulsive behaviour	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.64% 4/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.52% 2/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.9% 10/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.47% 2/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 3/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Intentional self-injury	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.6% 10/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.9% 15/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 9/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.8% 6/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.4% 2/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 4/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 4/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.97% 2/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.7% 2/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Major depression	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Mood altered	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Panic attack	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.90% 3/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.4% 2/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Social avoidant behaviour	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	5.3% 1/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Psychotic disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Stress	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Suicidal ideation	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.6% 10/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.52% 2/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.6% 8/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	4.2% 2/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 3/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.6% 7/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.4% 2/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.2% 4/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.0% 3/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.83% 2/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 3/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.97% 2/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Tachyphrenia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	5.3% 1/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.52% 2/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.58% 3/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.60% 2/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Tic	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.47% 2/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.60% 2/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.69% 2/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Trichotillomania	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Violence-related symptom	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.26% 1/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Skin and subcutaneous tissue disorders Acne	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.64% 4/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.78% 3/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.39% 2/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 6/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.90% 3/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.1% 2/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.7% 4/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Skin and subcutaneous tissue disorders Rash	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.32% 2/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.52% 2/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.39% 2/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.47% 2/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Blood and lymphatic system disorders Anaemia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Cheilitis	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Faecaloma	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Toothache	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
General disorders Non-cardiac chest pain	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
General disorders Pyrexia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.39% 2/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Immune system disorders Food allergy	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Immune system disorders Seasonal allergy	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Immune system disorders Hypersensitivity	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.39% 2/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Croup infectious	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Pharyngitis	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Concussion	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.39% 2/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Syncope	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Tremor	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Affective disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Mood swings	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Obsessive-compulsive disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.39% 2/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Obsessive-compulsive symptom	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Renal and urinary disorders Urinary hesitation	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Oppositional defiant disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.39% 2/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Paranoia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Restlessness	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.39% 2/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Self-injurious ideation	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Thinking abnormal	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Renal and urinary disorders Pollakiuria	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.19% 1/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	2.1% 1/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
General disorders Drug ineffective	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.47% 2/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.60% 2/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
General disorders Treatment noncompliance	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Bone contusion	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Fall	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Musculoskeletal and connective tissue disorders Spondylolysis	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Febrile convulsion	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Migraine	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Poor quality sleep	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Sedation	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Seizure	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Antisocial behaviour	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.97% 2/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Conversion disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Dysphoria	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Emotional distress	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.47% 2/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Mental status changes	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Purging	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Reproductive system and breast disorders Breast disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.47% 2/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Reproductive system and breast disorders Sexual dysfunction	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.23% 1/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Social circumstances Fight in school	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
General disorders Feeling abnormal	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
General disorders Feeling jittery	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
General disorders Influenza like illness	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Mononucleosis syndrome	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Pneumonia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.2% 1/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Defiant behaviour	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Disinhibition	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Emotional disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Learning disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Obsessive thoughts	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Renal and urinary disorders Incontinence	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.30% 1/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Endocrine disorders Precocious puberty	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.35% 1/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Dysphagia	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Gastrointestinal disorders Gastritis	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
General disorders Chest pain	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Nervous system disorders Somnolence	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	1.4% 1/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Injury, poisoning and procedural complications Sunburn	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Sleep terror	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.42% 1/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Attention-seeking behaviour	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Behaviour disorder	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.48% 1/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Infections and infestations Eye infection	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Psychiatric disorders Hallucinations, mixed	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.55% 1/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/614 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/3 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.16% 1/622 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/19 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/384 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/516 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/48 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/426 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/80 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/335 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/84 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/289 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/83 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/240 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/85 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/207 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/73 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.	0.00% 0/181 • Baseline up to 36 Months Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population at each visit for respective arms was evaluated. Since participants switched from 1 treatment to another, hence at each visit participants analyzed were different from previous visit.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER