Trial Outcomes & Findings for OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients (NCT NCT02161562)

Last Updated: 2018-09-13

Results Overview

The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the last 7 days of the second dosing period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

314 participants

Primary outcome timeframe

Last 7 days of second dosing period, 44 weeks

Results posted on

2018-09-13

Participant Flow

Patients were randomly assigned in a 4:3 ratio to Group A or Group B.

Participant milestones

Participant milestones
Measure	Omalizumab 150mg (A) Participants received 150mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period (at 150mg or 300mg) may have been implemented based on protocol-defined assessment criteria.	Omalizumab 300mg (B) Participants received 300mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period may have been implemented based on protocol-defined assessment criteria.
Overall Study STARTED	178	136
Overall Study COMPLETED	152	119
Overall Study NOT COMPLETED	26	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Omalizumab 150mg (A) Participants received 150mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period (at 150mg or 300mg) may have been implemented based on protocol-defined assessment criteria.	Omalizumab 300mg (B) Participants received 300mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period may have been implemented based on protocol-defined assessment criteria.
Overall Study Withdrawal by Subject	5	8
Overall Study Protocol Violation	9	4
Overall Study Pregnancy	1	2
Overall Study Lost to Follow-up	3	1
Overall Study Lack of Efficacy	4	1
Overall Study Adverse Event	1	1
Overall Study Participant moved back to home country	1	0
Overall Study Withdrew due to being out of the country	1	0
Overall Study Participant moved out of province	1	0

Baseline Characteristics

OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omalizumab 150mg (A) n=178 Participants Participants received 150mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period (at 150mg or 300mg) may have been implemented based on protocol-defined assessment criteria.	Omalizumab 300mg (B) n=136 Participants Participants received 300mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period may have been implemented based on protocol-defined assessment criteria.	Total n=314 Participants Total of all reporting groups
Age, Continuous	46.7 Years STANDARD_DEVIATION 14.03 • n=93 Participants	45.8 Years STANDARD_DEVIATION 13.60 • n=4 Participants	46.3 Years STANDARD_DEVIATION 13.83 • n=27 Participants
Sex: Female, Male Female	130 Participants n=93 Participants	99 Participants n=4 Participants	229 Participants n=27 Participants
Sex: Female, Male Male	48 Participants n=93 Participants	37 Participants n=4 Participants	85 Participants n=27 Participants

PRIMARY outcome

Timeframe: Last 7 days of second dosing period, 44 weeks

Population: Participants from groups A2 (n=12) and B2 (n=44) were considered for the analysis. Only Groups A2 and B2 participants, who had UAS7 scores collected at end of the second dosing period, were analyzed.

Outcome measures

Outcome measures
Measure	All Retreatment (A2&B2) n=49 Participants omalizumab 150 mg retreatment group + omalizummab 300 mg retreatment group	Retreatment (A2) n=12 Participants omalizumab 150 mg retreatment group	Retreatment (B2) n=37 Participants omalizumab 300 mg retreatment
Number of Participants Who Were Clinically Well-controlled (UAS7<=6) After the Initial Dosing Period, Relapsed (UAS7>=16) When Treatment Was Discontinued, and Who Achieved a UAS7 Score <=6 at the End of the Second Dosing Period (Retreatment A2 and B2)	43 Participants	10 Participants	33 Participants

SECONDARY outcome

Timeframe: 7 days prior to start of second dosing period and last 7 days of Second Dosing Period

Population: Group A3 participants (n=141) were considered for the analysis. Only Group A3 participants, who had UAS7 scores collected at the start and end of the second dosing period, were analyzed.

Outcome measures

Outcome measures
Measure	All Retreatment (A2&B2) n=130 Participants omalizumab 150 mg retreatment group + omalizummab 300 mg retreatment group	Retreatment (A2) omalizumab 150 mg retreatment group	Retreatment (B2) omalizumab 300 mg retreatment
The Difference in Urticaria Activity Score Over 7 Days (UAS7) Between the Start and End of the Second Dosing Period, in Participants That Step-up Treatment Dose During the Initial Dosing Period (Step-up A3)	-9.5 score on a scale Standard Deviation 10.54	—	—

SECONDARY outcome

Timeframe: Last 7 days of the second dosing period

Population: Group A3 participants (n=141) were considered for the analysis. Only Group A3 participants, who had UAS7 scores collected at the end of the second dosing period, were analyzed.

Outcome measures

Outcome measures
Measure	All Retreatment (A2&B2) n=130 Participants omalizumab 150 mg retreatment group + omalizummab 300 mg retreatment group	Retreatment (A2) omalizumab 150 mg retreatment group	Retreatment (B2) omalizumab 300 mg retreatment
Number of Participants With Urticaria Activity Score Over 7 Days (UAS7)≤6 at the End of the Second Dosing Period, in Participants Who Stepped-up Treatment Dosing (Step-up A3)	59 Participants	—	—

SECONDARY outcome

Timeframe: study drug withdrawal period, weeks 24 through 32

Population: The Retreatment participants were analyzed (A2=12, B2=44).

The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the time between end of initial dosing period to first occurence of UAS7 ≥ 16 will be evaluated.

Outcome measures

Outcome measures
Measure	All Retreatment (A2&B2) n=56 Participants omalizumab 150 mg retreatment group + omalizummab 300 mg retreatment group	Retreatment (A2) n=12 Participants omalizumab 150 mg retreatment group	Retreatment (B2) n=44 Participants omalizumab 300 mg retreatment
Time to Relapse (Urticaria Activity Score Over 7 Days (UAS7) ≥ 16) After Drug Withdrawal in Participants Who Responded to Initial Dosing Period (Retreatment A2 and B2)	4.7 Weeks Standard Deviation 2.37	4.8 Weeks Standard Deviation 2.70	4.7 Weeks Standard Deviation 2.31

SECONDARY outcome

Timeframe: last 7 days of initial dosing period, week 24, and last 7 days of second dosing period, week 36

Population: Group B3 participants (n=43) were considered for the analysis. Only B3 participants, who had UAS7 scores collected at both weeks 24 and 44, were included in the analysis.

Outcome measures

Outcome measures
Measure	All Retreatment (A2&B2) n=41 Participants omalizumab 150 mg retreatment group + omalizummab 300 mg retreatment group	Retreatment (A2) omalizumab 150 mg retreatment group	Retreatment (B2) omalizumab 300 mg retreatment
Difference in Urticaria Activity Score Over 7 Days (UAS7) Between End of Initial Dosing Period and the End of the Second Dosing Period, in Group B3 Participants Who Did Not Respond to the Initial Dosing Period	-2.0 score on a scale Standard Deviation 10.50	—	—

SECONDARY outcome

Timeframe: 7 days prior to Baseline visit, and last 7 days prior to week 24 of the initial dosing period

Population: Group B participants (n=136) were considered for the analysis. Only Group B participants, who had both baseline and week 24 UAS7 scores collected, were analyzed.

Outcome measures

Outcome measures
Measure	All Retreatment (A2&B2) n=131 Participants omalizumab 150 mg retreatment group + omalizummab 300 mg retreatment group	Retreatment (A2) omalizumab 150 mg retreatment group	Retreatment (B2) omalizumab 300 mg retreatment
The Change in Urticaria Activity Score Over 7 Days (UAS7) From Baseline to Week 24 in Group B Participants	-23.8 score on a scale Standard Deviation 10.08	—	—

SECONDARY outcome

Timeframe: 7 days prior to Baseline visit, and last 7 days of second dosing period

Population: Group A (n=178) and Group B (n=136) participants were considered for the analysis. Only Group A and Group B participants who had both baseline and week 44 UAS7 scores collected, were analyzed.

Outcome measures

Outcome measures
Measure	All Retreatment (A2&B2) n=156 Participants omalizumab 150 mg retreatment group + omalizummab 300 mg retreatment group	Retreatment (A2) n=122 Participants omalizumab 150 mg retreatment group	Retreatment (B2) n=278 Participants omalizumab 300 mg retreatment
Change in Urticaria Activity Score Over 7 Days (UAS7) Between Baseline and End of Second Dosing Period	-18.7 score on a scale Standard Deviation 11.66	-23.0 score on a scale Standard Deviation 10.92	-20.6 score on a scale Standard Deviation 11.53

SECONDARY outcome

Timeframe: Week 8 of initial dosing phase and week 8 of second dosing phase

Population: Only Groups A2 and B2 participants, who had UAS7 scores collected at week 8 of initial dosing period and week 8 of second dosing period, were analyzed.

Outcome measures

Outcome measures
Measure	All Retreatment (A2&B2) n=56 Participants omalizumab 150 mg retreatment group + omalizummab 300 mg retreatment group	Retreatment (A2) n=12 Participants omalizumab 150 mg retreatment group	Retreatment (B2) n=44 Participants omalizumab 300 mg retreatment
The Number of Participants Who Remained Well-controlled (UAS7<=6) or Who Had Achieved UAS=0 at Phase 4 (Second Dosing Period) Week 8 During Retreatment After Being Well Controlled or Achieving UAS7=0 at Phase 2 (Initial Dosing Period) Week 8 UAS7=0 at week 8 of the initial dosing period	34 Participants	10 Participants	24 Participants
The Number of Participants Who Remained Well-controlled (UAS7<=6) or Who Had Achieved UAS=0 at Phase 4 (Second Dosing Period) Week 8 During Retreatment After Being Well Controlled or Achieving UAS7=0 at Phase 2 (Initial Dosing Period) Week 8 UAS7=0 at week 8 of the second dosing period	23 Participants	5 Participants	18 Participants
The Number of Participants Who Remained Well-controlled (UAS7<=6) or Who Had Achieved UAS=0 at Phase 4 (Second Dosing Period) Week 8 During Retreatment After Being Well Controlled or Achieving UAS7=0 at Phase 2 (Initial Dosing Period) Week 8 UAS7<=6 at week 8 of the initial dosing period	43 Participants	12 Participants	31 Participants
The Number of Participants Who Remained Well-controlled (UAS7<=6) or Who Had Achieved UAS=0 at Phase 4 (Second Dosing Period) Week 8 During Retreatment After Being Well Controlled or Achieving UAS7=0 at Phase 2 (Initial Dosing Period) Week 8 UAS7<=6 at week 8 of the second dosing period	36 Participants	9 Participants	27 Participants

Adverse Events

Omalizumab 150 mg (A)

Serious events: 2 serious events

Other events: 119 other events

Deaths: 0 deaths

Maintained Response (A1)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Retreatment (A2)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Step-up Treatment Group (A3)

Serious events: 2 serious events

Other events: 94 other events

Deaths: 0 deaths

Omalizumab 300 mg (B)

Serious events: 6 serious events

Other events: 109 other events

Deaths: 0 deaths

Maintained Response(B1)

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Retreatment (B2)

Serious events: 2 serious events

Other events: 37 other events

Deaths: 0 deaths

Extended Treatment (B3)

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Omalizumab 150 mg (A) n=178 participants at risk Participants received 150mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period (at 150mg or 300mg) may have been implemented based on protocol-defined assessment criteria.	Maintained Response (A1) n=15 participants at risk omalizumab 150 mg maintained response group	Retreatment (A2) n=12 participants at risk omalizumab 150 mg retreatment group	Step-up Treatment Group (A3) n=141 participants at risk Step-up treatment from omalizumab 150 mg to 300 mg	Omalizumab 300 mg (B) n=136 participants at risk Participants received 300mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period may have been implemented based on protocol-defined assessment criteria.	Maintained Response(B1) n=44 participants at risk omalizumab 300 mg Maintained Response group	Retreatment (B2) n=44 participants at risk omalizumab 300 mg retreatment	Extended Treatment (B3) n=43 participants at risk omalizumab 300 mg extended treatment
Cardiac disorders Cardiac failure	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Congenital, familial and genetic disorders Porphyria acute	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Hepatobiliary disorders Cholecystitis chronic	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Maternal exposure during pregnancy	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.

Other adverse events

Other adverse events
Measure	Omalizumab 150 mg (A) n=178 participants at risk Participants received 150mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period (at 150mg or 300mg) may have been implemented based on protocol-defined assessment criteria.	Maintained Response (A1) n=15 participants at risk omalizumab 150 mg maintained response group	Retreatment (A2) n=12 participants at risk omalizumab 150 mg retreatment group	Step-up Treatment Group (A3) n=141 participants at risk Step-up treatment from omalizumab 150 mg to 300 mg	Omalizumab 300 mg (B) n=136 participants at risk Participants received 300mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period may have been implemented based on protocol-defined assessment criteria.	Maintained Response(B1) n=44 participants at risk omalizumab 300 mg Maintained Response group	Retreatment (B2) n=44 participants at risk omalizumab 300 mg retreatment	Extended Treatment (B3) n=43 participants at risk omalizumab 300 mg extended treatment
Eye disorders Conjunctival haemorrhage	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Eye disorders Eye oedema	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Blood and lymphatic system disorders Anaemia	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Cardiac disorders Cardiac failure	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Cardiac disorders Tachycardia	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Congenital, familial and genetic disorders Dermoid cyst	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Ear and labyrinth disorders Ear pain	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Ear and labyrinth disorders Tinnitus	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Ear and labyrinth disorders Vertigo	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Endocrine disorders Basedow's disease	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Endocrine disorders Goitre	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Endocrine disorders Hypothyroidism	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Eye disorders Blepharitis	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Eye disorders Eye pruritus	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Eye disorders Hypoaesthesia eye	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Eye disorders Myopia	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Eye disorders Ulcerative keratitis	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Abdominal distension	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Abdominal mass	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Abdominal pain	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	3.7% 5/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Anal incontinence	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Breath odour	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Constipation	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Dental caries	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Diarrhoea	2.8% 5/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.1% 3/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.9% 4/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Dry mouth	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Dyspepsia	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Enteritis	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Flatulence	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Food poisoning	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Gastritis	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Gastrointestinal hypomotility	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Gingival bleeding	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Haemorrhoids	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Lip oedema	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Mouth swelling	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Mouth ulceration	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Nausea	5.1% 9/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	5.7% 8/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	5.9% 8/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	11.6% 5/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Noninfective gingivitis	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Oral pain	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Reflux gastritis	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Toothache	1.7% 3/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.1% 3/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Umbilical hernia	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Gastrointestinal disorders Vomiting	2.8% 5/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Application site rash	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Asthenia	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Chest pain	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Chills	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Discomfort	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.9% 4/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.8% 3/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Drug ineffective	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Face oedema	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Fatigue	6.7% 12/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	7.8% 11/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.4% 6/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	7.0% 3/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Granuloma	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Influenza like illness	1.7% 3/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.1% 3/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	3.7% 5/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	7.0% 3/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Injection site bruising	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Injection site pain	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Injection site pruritus	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Injection site reaction	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Injection site swelling	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Malaise	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Oedema peripheral	2.8% 5/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	13.3% 2/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.1% 3/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Pain	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Peripheral swelling	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Polyp	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
General disorders Pyrexia	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Hepatobiliary disorders Cholelithiasis	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Hepatobiliary disorders Hepatic cyst	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Immune system disorders Food allergy	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Immune system disorders Hypersensitivity	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Acute sinusitis	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Bronchitis	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Burn infection	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Conjunctivitis	1.7% 3/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Cystitis	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Diverticulitis	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Ear infection	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Eye infection	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Eye infection bacterial	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Folliculitis	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Fungal infection	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Fungal skin infection	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Gastroenteritis	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Gastroenteritis viral	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.4% 6/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	7.0% 3/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Gingivitis	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Impetigo	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Infection parasitic	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Influenza	5.1% 9/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	5.7% 8/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.9% 4/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.8% 3/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Kidney infection	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Localised infection	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Lower respiratory tract infection	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Lower respiratory tract infection viral	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Nail infection	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Nasopharyngitis	16.3% 29/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	20.0% 3/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	25.0% 3/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	14.2% 20/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	17.6% 24/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	11.4% 5/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	22.7% 10/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	18.6% 8/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Oesophageal candidiasis	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Onychomycosis	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Oral herpes	1.7% 3/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.1% 3/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Otitis media	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Paronychia	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Pharyngitis	2.2% 4/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.8% 4/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Pharyngitis bacterial	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Pharyngitis streptococcal	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Pharyngotonsillitis	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Pneumonia	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Pulpitis dental	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Rash pustular	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Respiratory tract infection	1.7% 3/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Rhinitis	1.7% 3/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	3.7% 5/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	9.1% 4/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Metabolism and nutrition disorders Hyperuricaemia	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Sialoadenitis	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Sinusitis	5.6% 10/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	5.7% 8/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.4% 6/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	9.1% 4/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Tinea pedis	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Tonsillitis	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Tooth abscess	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Tooth infection	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Upper respiratory tract infection	5.1% 9/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	13.3% 2/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	16.7% 2/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	3.5% 5/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	11.0% 15/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	9.1% 4/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	18.2% 8/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Urinary tract infection	3.4% 6/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	3.5% 5/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.4% 6/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.8% 3/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	7.0% 3/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Vaginal infection	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Viral infection	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Infections and infestations Vulvovaginal mycotic infection	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Arthropod bite	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Arthropod sting	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Bladder injury	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Concussion	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Contusion	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Foot fracture	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Fractured ischium	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Head injury	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Injury	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Joint injury	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Laceration	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Ligament injury	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Ligament rupture	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Ligament sprain	2.8% 5/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.8% 4/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.9% 4/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.8% 3/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Limb crushing injury	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Limb injury	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Muscle rupture	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Procedural dizziness	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Procedural pain	2.2% 4/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.1% 3/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Scar	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Spinal compression fracture	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Sunburn	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Tooth fracture	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Traumatic haematoma	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Injury, poisoning and procedural complications Wound	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Investigations Blood cholesterol increased	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Investigations Blood iron decreased	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Investigations Haemoglobin decreased	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Investigations Spirometry abnormal	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Investigations Weight decreased	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Metabolism and nutrition disorders Decreased appetite	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Metabolism and nutrition disorders Diabetes mellitus	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Metabolism and nutrition disorders Gout	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Metabolism and nutrition disorders Hypokalaemia	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Loss of consciousness	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Arthralgia	4.5% 8/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	5.0% 7/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	7.4% 10/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	9.1% 4/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.8% 3/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	7.0% 3/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Arthritis	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Back pain	3.9% 7/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	3.5% 5/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	5.1% 7/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	9.3% 4/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Bursitis	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Joint swelling	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Muscle contracture	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Muscle spasms	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Muscle tightness	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.8% 3/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Myalgia	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	3.7% 5/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Pain in extremity	2.2% 4/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	3.7% 5/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Musculoskeletal and connective tissue disorders Tendonitis	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral fibroma	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pyogenic granuloma	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Ageusia	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Cluster headache	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Dizziness	1.7% 3/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.4% 6/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	7.0% 3/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Facial paralysis	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Headache	12.9% 23/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	13.3% 2/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	16.7% 2/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	12.8% 18/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	14.0% 19/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	11.4% 5/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	11.4% 5/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	20.9% 9/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Hyperaesthesia	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Hypoaesthesia	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Lumbar radiculopathy	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Migraine	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Paraesthesia	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Sciatica	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Somnolence	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Syncope	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Tension headache	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Nervous system disorders Vascular headache	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Psychiatric disorders Anxiety	2.2% 4/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.1% 3/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Psychiatric disorders Emotional distress	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Psychiatric disorders Insomnia	4.5% 8/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	5.0% 7/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Psychiatric disorders Irritability	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Psychiatric disorders Panic attack	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Psychiatric disorders Sleep disorder	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Psychiatric disorders Stress	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Renal and urinary disorders Dysuria	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Renal and urinary disorders Nephrolithiasis	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Renal and urinary disorders Renal cyst	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Reproductive system and breast disorders Breast cyst	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Reproductive system and breast disorders Breast pain	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Reproductive system and breast disorders Dysmenorrhoea	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Reproductive system and breast disorders Menstruation irregular	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Reproductive system and breast disorders Pelvic pain	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Reproductive system and breast disorders Vaginal discharge	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Asthma	1.7% 3/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 9/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	13.3% 2/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	25.0% 3/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.8% 4/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.4% 6/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.8% 3/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.7% 3/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Nasal mucosal disorder	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Nasal oedema	1.7% 3/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.1% 3/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Nasal turbinate hypertrophy	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.9% 7/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.3% 6/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Alopecia	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Angioedema	2.2% 4/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Chloasma	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Dermatitis	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	3.7% 5/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Dermatitis contact	1.7% 3/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.1% 3/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Ecchymosis	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Eczema	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.9% 4/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Erythema	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Excessive granulation tissue	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Hand dermatitis	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Lichen planus	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Onychoclasis	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Prurigo	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Pruritus	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.7% 1/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.9% 4/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Psoriasis	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Rash	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.4% 2/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.2% 3/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Rash papular	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Skin erosion	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Skin swelling	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Solar lentigo	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Urticaria	5.1% 9/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	5.7% 8/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.1% 11/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.8% 3/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	6.8% 3/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	11.6% 5/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Skin and subcutaneous tissue disorders Xeroderma	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Vascular disorders Flushing	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Vascular disorders Hyperaemia	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Vascular disorders Hypertension	1.1% 2/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.71% 1/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	3.7% 5/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.5% 2/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	4.7% 2/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Vascular disorders Hypotension	0.56% 1/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	8.3% 1/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	1.5% 2/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.
Vascular disorders Peripheral coldness	0.00% 0/178 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/15 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/12 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/141 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.74% 1/136 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	0.00% 0/44 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.	2.3% 1/43 The serious adverse events (SAEs) count for the overall B group = 8 but the sum of the subgroups = 7. Per protocol, the subgroup assignment is based on the UAS7 outcome. The discrepancy mentioned previously is due to the fact that one participant was not assigned to a B subgroup because this participant was discontinued prior to finalizing phase 2.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER