Trial Outcomes & Findings for A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis (NCT NCT02207231)

NCT ID: NCT02207231

Last Updated: 2021-07-23

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

837 participants

Primary outcome timeframe

Week 16

Results posted on

2021-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Then Guselkumab 100 mg Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP). Participants then crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 and placebo matched to adalimumab subcutaneous injection at Weeks 17, 19, 21, and 23 and every 2 weeks thereafter through Week 47 in the active controlled period (ACP). Participants continued to receive guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open-label treatment period.	Guselkumab 100 mg Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47. Participants receiving guselkumab continued to receive guselkumab 100mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open label period.	Adalimumab Then Guselkumab 100 mg Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.	Guselkumab Combined All participants who received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.
Placebo Controlled Period: Week 0 - 16 STARTED	174	329	334	0
Placebo Controlled Period: Week 0 - 16 Treated	174	329	333	0
Placebo Controlled Period: Week 0 - 16 COMPLETED	167	322	324	0
Placebo Controlled Period: Week 0 - 16 NOT COMPLETED	7	7	10	0
Active Controlled Period: Week 16 - 48 STARTED	165	322	324	0
Active Controlled Period: Week 16 - 48 COMPLETED	162	301	281	0
Active Controlled Period: Week 16 - 48 NOT COMPLETED	3	21	43	0
Open-label Guselkumab: Week 48 - 264 STARTED	0	0	280	463
Open-label Guselkumab: Week 48 - 264 COMPLETED	0	0	242	380
Open-label Guselkumab: Week 48 - 264 NOT COMPLETED	0	0	38	83

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Then Guselkumab 100 mg Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP). Participants then crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 and placebo matched to adalimumab subcutaneous injection at Weeks 17, 19, 21, and 23 and every 2 weeks thereafter through Week 47 in the active controlled period (ACP). Participants continued to receive guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open-label treatment period.	Guselkumab 100 mg Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47. Participants receiving guselkumab continued to receive guselkumab 100mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open label period.	Adalimumab Then Guselkumab 100 mg Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.	Guselkumab Combined All participants who received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.
Placebo Controlled Period: Week 0 - 16 Adverse Event	2	4	2	0
Placebo Controlled Period: Week 0 - 16 Lack of Efficacy	2	0	1	0
Placebo Controlled Period: Week 0 - 16 Lost to Follow-up	1	1	1	0
Placebo Controlled Period: Week 0 - 16 Withdrawal by Subject	2	0	4	0
Placebo Controlled Period: Week 0 - 16 Protocol Violation	0	0	1	0
Placebo Controlled Period: Week 0 - 16 Noncompliance	0	2	1	0
Active Controlled Period: Week 16 - 48 Adverse Event	1	6	10	0
Active Controlled Period: Week 16 - 48 Pregnancy	0	0	1	0
Active Controlled Period: Week 16 - 48 Lack of Efficacy	0	3	11	0
Active Controlled Period: Week 16 - 48 Lost to Follow-up	1	2	5	0
Active Controlled Period: Week 16 - 48 Withdrawal by Subject	1	4	10	0
Active Controlled Period: Week 16 - 48 Protocol Violation	0	1	0	0
Active Controlled Period: Week 16 - 48 Noncompliance	0	3	3	0
Active Controlled Period: Week 16 - 48 Other	0	2	3	0
Open-label Guselkumab: Week 48 - 264 Adverse Event	0	0	12	19
Open-label Guselkumab: Week 48 - 264 Death	0	0	1	3
Open-label Guselkumab: Week 48 - 264 Pregnancy	0	0	3	7
Open-label Guselkumab: Week 48 - 264 Lack of Efficacy	0	0	2	4
Open-label Guselkumab: Week 48 - 264 Lost to Follow-up	0	0	6	11
Open-label Guselkumab: Week 48 - 264 Withdrawal by Subject	0	0	10	28
Open-label Guselkumab: Week 48 - 264 Other	0	0	4	11

Baseline Characteristics

A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Then Guselkumab 100 mg n=174 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP). Participants then crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 and placebo matched to adalimumab subcutaneous injection at Weeks 17, 19, 21, and 23 and every 2 weeks thereafter through Week 47 in the active controlled period (ACP). Participants continued to receive guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open-label treatment period.	Guselkumab 100 mg n=329 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47. Participants receiving guselkumab continued to receive guselkumab 100mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open label period.	Adalimumab Then Guselkumab 100 mg n=334 Participants Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.	Total n=837 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	164 Participants n=5 Participants	311 Participants n=7 Participants	315 Participants n=5 Participants	790 Participants n=4 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	18 Participants n=7 Participants	16 Participants n=5 Participants	44 Participants n=4 Participants
Age, Continuous	44.9 years STANDARD_DEVIATION 12.9 • n=5 Participants	43.9 years STANDARD_DEVIATION 12.74 • n=7 Participants	42.9 years STANDARD_DEVIATION 12.58 • n=5 Participants	43.7 years STANDARD_DEVIATION 12.72 • n=4 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	89 Participants n=7 Participants	85 Participants n=5 Participants	229 Participants n=4 Participants
Sex: Female, Male Male	119 Participants n=5 Participants	240 Participants n=7 Participants	249 Participants n=5 Participants	608 Participants n=4 Participants
Region of Enrollment Australia	13 participants n=5 Participants	23 participants n=7 Participants	21 participants n=5 Participants	57 participants n=4 Participants
Region of Enrollment Taiwan, Province Of China	15 participants n=5 Participants	31 participants n=7 Participants	27 participants n=5 Participants	73 participants n=4 Participants
Region of Enrollment Hungary	7 participants n=5 Participants	9 participants n=7 Participants	14 participants n=5 Participants	30 participants n=4 Participants
Region of Enrollment Poland	22 participants n=5 Participants	42 participants n=7 Participants	43 participants n=5 Participants	107 participants n=4 Participants
Region of Enrollment Russia	21 participants n=5 Participants	48 participants n=7 Participants	49 participants n=5 Participants	118 participants n=4 Participants
Region of Enrollment Canada	24 participants n=5 Participants	50 participants n=7 Participants	48 participants n=5 Participants	122 participants n=4 Participants
Region of Enrollment United States	38 participants n=5 Participants	65 participants n=7 Participants	67 participants n=5 Participants	170 participants n=4 Participants
Region of Enrollment Germany	23 participants n=5 Participants	41 participants n=7 Participants	43 participants n=5 Participants	107 participants n=4 Participants
Region of Enrollment Spain	4 participants n=5 Participants	8 participants n=7 Participants	13 participants n=5 Participants	25 participants n=4 Participants
Region of Enrollment Korea, Democratic People'S Republic Of	7 participants n=5 Participants	12 participants n=7 Participants	9 participants n=5 Participants	28 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.

Outcome measures

Outcome measures
Measure	Placebo n=174 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=329 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16	6.9 percentage of participants	85.1 percentage of participants

PRIMARY outcome

Timeframe: Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	Placebo n=174 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=329 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16	2.9 percentage of participants	73.3 percentage of participants

SECONDARY outcome

Timeframe: Week 24 and 48

Population: Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.

Outcome measures

Outcome measures
Measure	Placebo n=329 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=334 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48 Week 24	52.6 percentage of participants	29.3 percentage of participants
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48 Week 48	50.5 percentage of participants	25.7 percentage of participants

SECONDARY outcome

Timeframe: Week 24 and 48

Outcome measures

Outcome measures
Measure	Placebo n=329 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=334 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48 Week 24	84.2 percentage of participants	61.7 percentage of participants
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48 Week 48	80.5 percentage of participants	55.4 percentage of participants

SECONDARY outcome

Timeframe: Week 24 and 48

Outcome measures

Outcome measures
Measure	Placebo n=329 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=334 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48 Week 24	80.2 percentage of participants	53.0 percentage of participants
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48 Week 48	76.3 percentage of participants	47.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Randomized analysis set included all participants who were randomized at Week 0 and have a baseline DLQI score.

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. This secondary outcome measure was planned to include only the placebo and guselkumab arms.

Outcome measures

Outcome measures
Measure	Placebo n=174 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=329 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group	-0.6 units on a scale Standard Deviation 6.36	-11.2 units on a scale Standard Deviation 7.24

SECONDARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Placebo n=329 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=334 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16	85.1 percentage of participants	65.9 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Placebo n=329 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=334 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16	73.3 percentage of participants	49.7 percentage of participants

SECONDARY outcome

Timeframe: Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.

Outcome measures

Outcome measures
Measure	Placebo n=329 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=334 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16	91.2 percentage of participants	73.1 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: Population analyzed included only randomized participants at Week 0 who had an ss-IGA score greater than or equal to (\>=) 2 at baseline.

The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.

Outcome measures

Outcome measures
Measure	Placebo n=145 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=277 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group	14.5 percentage of participants	83.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: PSSD analysis set included all those participants who had baseline PSSD scores as the average score of at least 4 days out of the 7 days prior to the Week 0 visit.

The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom \[or Sign\] score = average value\*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.

Outcome measures

Outcome measures
Measure	Placebo n=129 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=249 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group	-3.0 units on a scale Standard Deviation 19.56	-41.9 units on a scale Standard Deviation 24.61

SECONDARY outcome

Timeframe: Week 24

Population: PSSD analysis set included all those participants who were randomized at Week 0 and had baseline PSSD score greater than 0.

Outcome measures

Outcome measures
Measure	Placebo n=248 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=273 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24	36.3 percentage of participants	21.6 percentage of participants

SECONDARY outcome

Timeframe: Week 252

Population: Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=391 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=246 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved PASI 90 Response at Week 252	84.1 percentage of participants	82.5 percentage of participants

SECONDARY outcome

Timeframe: Week 252

The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=391 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=246 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved PASI 75 Response at Week 252	93.9 percentage of participants	93.1 percentage of participants

SECONDARY outcome

Timeframe: Week 252

The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=391 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=246 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252	82.4 percentage of participants	82.9 percentage of participants

SECONDARY outcome

Timeframe: Week 252

Population: Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline DLQI score \>1. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=374 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=235 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants With a DLQI Score of 0 or 1 at Week 252	72.7 percentage of participants	74.0 percentage of participants

SECONDARY outcome

Timeframe: Week 252

Population: Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD symptom score \>0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.

The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom score = average value\*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=297 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=200 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252	42.4 percentage of participants	48.0 percentage of participants

SECONDARY outcome

Timeframe: Week 252

Population: Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD sign score \>0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.

The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Sign score = average value\*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=297 Participants Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).	Guselkumab n=201 Participants Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252	33.0 percentage of participants	37.8 percentage of participants

Adverse Events

Placebo (PCP)

Serious events: 3 serious events

Other events: 51 other events

Deaths: 0 deaths

Guselkumab 100 mg (PCP)

Serious events: 8 serious events

Other events: 101 other events

Deaths: 0 deaths

Adalimumab (PCP)

Serious events: 6 serious events

Other events: 98 other events

Deaths: 0 deaths

Placebo Then Guselkumab 100 mg (ACP)

Serious events: 5 serious events

Other events: 67 other events

Deaths: 0 deaths

Guselkumab 100 mg (ACP)

Serious events: 8 serious events

Other events: 134 other events

Deaths: 0 deaths

Adalimumab (ACP)

Serious events: 10 serious events

Other events: 137 other events

Deaths: 0 deaths

Adalimumab Then Guselkumab 100 mg (After ACP)

Serious events: 34 serious events

Other events: 193 other events

Deaths: 0 deaths

Guselkumab Combined

Serious events: 79 serious events

Other events: 307 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (PCP) n=174 participants at risk Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12 during the placebo controlled period.	Guselkumab 100 mg (PCP) n=329 participants at risk Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 during the placebo controlled period.	Adalimumab (PCP) n=333 participants at risk Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Week 1 and once every other week thereafter through Week 15 during the placebo controlled period.	Placebo Then Guselkumab 100 mg (ACP) n=165 participants at risk Participants initially randomized to placebo crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 in the active controlled period (ACP).	Guselkumab 100 mg (ACP) n=324 participants at risk Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.	Adalimumab (ACP) n=326 participants at risk Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.	Adalimumab Then Guselkumab 100 mg (After ACP) n=280 participants at risk Participants initially randomized to adalimumab entered a washout period after their final dose at Week 47 and crossed over to receive guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252. This arm reports safety data for participants that crossed over to guselkumab from adalimumab.	Guselkumab Combined n=494 participants at risk All participants who crossed over to receive guselkumab (GUS) 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab. Participants that discontinued treatment prematurely were followed up for safety and hence were included in the safety data. Therefore, combined safety results are reported for this arm. This arm reports safety data for guselkumab.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.40% 2/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Cardiac disorders Angina Pectoris	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Cardiac disorders Aortic Valve Incompetence	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Cardiac disorders Cardiac Failure	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Cardiac disorders Coronary Artery Disease	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Cardiac disorders Myocardial Infarction	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 3/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Cardiac disorders Myocardial Ischaemia	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Cardiac disorders Sinus Node Dysfunction	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 1/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Congenital, familial and genetic disorders Dermoid Cyst	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Gastrointestinal disorders Abdominal Hernia	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Gastrointestinal disorders Colitis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Gastrointestinal disorders Duodenal Ulcer	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Gastrointestinal disorders Enterocutaneous Fistula	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Gastrointestinal disorders Gastritis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Gastrointestinal disorders Haemorrhoids	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 1/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Gastrointestinal disorders Intestinal Strangulation	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Gastrointestinal disorders Large Intestine Polyp	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Gastrointestinal disorders Pancreatitis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Gastrointestinal disorders Umbilical Hernia	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
General disorders Hernia	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
General disorders Non-Cardiac Chest Pain	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Hepatobiliary disorders Cholangitis Acute	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Hepatobiliary disorders Cholecystitis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Hepatobiliary disorders Cholelithiasis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Hepatobiliary disorders Hepatic Failure	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Hepatobiliary disorders Ischaemic Hepatitis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Abdominal Abscess	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Abscess Limb	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Acute Sinusitis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Anal Abscess	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 1/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Appendicitis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 2/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.81% 4/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Cellulitis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.60% 2/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 3/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Chronic Tonsillitis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Diverticulitis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Erysipelas	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Ovarian Abscess	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Pneumonia	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Pneumonia Staphylococcal	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Postoperative Wound Infection	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Pyelonephritis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Scrotal Abscess	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Sepsis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Varicella	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Abdominal Injury	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Avulsion Fracture	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Cervical Vertebral Fracture	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Chest Injury	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Clavicle Fracture	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Concussion	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Craniocerebral Injury	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Foreign Body	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Humerus Fracture	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Jaw Fracture	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Joint Dislocation	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Ligament Rupture	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.40% 2/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Meniscus Injury	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 1/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Multiple Injuries	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Post Procedural Fistula	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Procedural Hypotension	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Soft Tissue Injury	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Spinal Fracture	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Tendon Injury	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Investigations Human Chorionic Gonadotropin Increased	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Metabolism and nutrition disorders Gout	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Metabolism and nutrition disorders Obesity	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Chondromalacia	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Dupuytren's Contracture	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Intervertebral Disc Degeneration	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Psychiatric disorders Suicidal Ideation	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Psychiatric disorders Suicide Attempt	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Renal and urinary disorders Nephrolithiasis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Renal and urinary disorders Ureterolithiasis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Renal and urinary disorders Urinary Retention	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Reproductive system and breast disorders Ovarian Cyst Ruptured	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Reproductive system and breast disorders Uterine Polyp	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.40% 2/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Respiratory, thoracic and mediastinal disorders Pulmonary Sarcoidosis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Skin and subcutaneous tissue disorders Erythema Nodosum	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Skin and subcutaneous tissue disorders Erythrodermic Psoriasis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Skin and subcutaneous tissue disorders Lichen Planus	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 1/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Skin and subcutaneous tissue disorders Psoriasis	0.57% 1/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Vascular disorders Aortic Aneurysm	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Vascular disorders Deep Vein Thrombosis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Vascular disorders Hypertensive Crisis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Vascular disorders Peripheral Arterial Occlusive Disease	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Vascular disorders Peripheral Artery Stenosis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Vascular disorders Thrombophlebitis Superficial	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Lateral Patellar Compression Syndrome	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Meniscal Degeneration	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 1/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.57% 1/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.71% 2/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 3/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Trigger Finger	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Astrocytoma	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-Cell Lymphoma	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.40% 2/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Epiglottic Cancer	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Papillary Breast Carcinoma	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal Cancer	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma in Situ	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary Cystadenoma Lymphomatosum	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Adenocarcinoma	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.40% 2/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.40% 2/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Nervous system disorders Balance Disorder	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Nervous system disorders Carpal Tunnel Syndrome	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Nervous system disorders Cerebrovascular Accident	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Nervous system disorders Idiopathic Partial Epilepsy	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Nervous system disorders Lacunar Infarction	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Nervous system disorders Paraesthesia	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Nervous system disorders Sciatica	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Pregnancy, puerperium and perinatal conditions Abortion Missed	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.36% 1/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Psychiatric disorders Anxiety	0.57% 1/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Psychiatric disorders Completed Suicide	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Psychiatric disorders Psychotic Disorder	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Psychiatric disorders Substance Abuse	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.20% 1/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.

Other adverse events

Other adverse events
Measure	Placebo (PCP) n=174 participants at risk Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12 during the placebo controlled period.	Guselkumab 100 mg (PCP) n=329 participants at risk Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 during the placebo controlled period.	Adalimumab (PCP) n=333 participants at risk Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Week 1 and once every other week thereafter through Week 15 during the placebo controlled period.	Placebo Then Guselkumab 100 mg (ACP) n=165 participants at risk Participants initially randomized to placebo crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 in the active controlled period (ACP).	Guselkumab 100 mg (ACP) n=324 participants at risk Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.	Adalimumab (ACP) n=326 participants at risk Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.	Adalimumab Then Guselkumab 100 mg (After ACP) n=280 participants at risk Participants initially randomized to adalimumab entered a washout period after their final dose at Week 47 and crossed over to receive guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252. This arm reports safety data for participants that crossed over to guselkumab from adalimumab.	Guselkumab Combined n=494 participants at risk All participants who crossed over to receive guselkumab (GUS) 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab. Participants that discontinued treatment prematurely were followed up for safety and hence were included in the safety data. Therefore, combined safety results are reported for this arm. This arm reports safety data for guselkumab.
Gastrointestinal disorders Diarrhoea	1.1% 2/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 2/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.2% 4/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.6% 6/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	2.5% 8/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.2% 4/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	4.6% 13/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	5.7% 28/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
General disorders Injection Site Erythema	0.57% 1/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.8% 6/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	5.1% 17/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.8% 3/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.2% 4/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.4% 11/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	2.5% 7/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.0% 5/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Bronchitis	1.1% 2/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 2/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.90% 3/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.0% 5/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.2% 4/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	2.1% 7/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	6.8% 19/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	4.7% 23/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Gastroenteritis	1.1% 2/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.5% 5/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.60% 2/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.8% 3/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.4% 11/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.2% 4/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	5.0% 14/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	5.1% 25/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Influenza	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 2/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.60% 2/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 1/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.62% 2/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 2/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	5.7% 16/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	4.0% 20/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Nasopharyngitis	9.8% 17/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	9.1% 30/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	10.8% 36/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	20.6% 34/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	20.1% 65/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	17.5% 57/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	31.8% 89/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	30.0% 148/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Pharyngitis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.60% 2/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 1/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.5% 5/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	2.1% 7/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	6.1% 17/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.6% 18/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Sinusitis	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.91% 3/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.8% 3/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	2.2% 7/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.8% 6/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	5.0% 14/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.8% 19/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Infections and infestations Upper Respiratory Tract Infection	5.2% 9/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	7.6% 25/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	4.8% 16/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	10.3% 17/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	9.6% 31/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	10.1% 33/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	24.6% 69/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	21.7% 107/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 3/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.3% 11/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	2.4% 8/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.2% 2/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.1% 10/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	2.5% 8/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	9.3% 26/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	7.5% 37/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Back Pain	1.1% 2/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.8% 6/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.5% 5/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 1/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	2.2% 7/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.7% 12/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	7.9% 22/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	5.7% 28/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Musculoskeletal and connective tissue disorders Psoriatic Arthropathy	0.00% 0/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.30% 1/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.31% 1/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	5.0% 14/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	2.4% 12/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Nervous system disorders Headache	4.0% 7/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	4.3% 14/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.9% 13/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 1/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	2.2% 7/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	4.9% 16/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	6.1% 17/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	5.7% 28/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Respiratory, thoracic and mediastinal disorders Cough	0.57% 1/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.61% 2/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.2% 4/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.6% 6/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.1% 10/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	2.5% 8/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	7.1% 20/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	4.9% 24/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Skin and subcutaneous tissue disorders Pruritus	5.7% 10/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.5% 5/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	2.1% 7/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.00% 0/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	0.93% 3/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.8% 6/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	2.5% 7/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.2% 16/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
Vascular disorders Hypertension	2.3% 4/174 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.0% 10/329 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	2.1% 7/333 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.6% 6/165 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	1.5% 5/324 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	3.1% 10/326 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	6.1% 17/280 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.	8.1% 40/494 • Baseline (Week 0) up to Week 264 Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.

Additional Information

Senior Director

Janssen Research & Development, LLC

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER